848 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9, 710, and 723

[OPPT–2002–0054; FRL–6767–4] 

RIN 2070–AC61

TSCA Inventory Update Rule 

Amendments

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is promulgating 

amendments to the Toxic Substances 

Control Act (TSCA) section 8(a) 

Inventory Update Rule (IUR). The IUR 

currently requires manufacturers 

(including importers) of certain 

chemical substances on the TSCA 

Chemical Substances Inventory to report 

data on each chemical’s current 

production volume, site–limited status, 

and plant site information every 4 years. 

Through these IUR amendments (IURA), 

EPA is requiring the reporting of 

additional data for certain chemicals to 

assist EPA and others in screening 

potential exposures and risks resulting 

from industrial chemical operations and 

commercial and consumer uses of TSCA 

chemical substances. EPA is also 

modifying the IUR reporting and 

recordkeeping requirements, removing 

one reporting exemption and creating 

others, and modifying its procedures for 

making Confidential Business 

Information claims. EPA is also making 

certain non–substantive technical 

corrections.

DATES: This final rule is effective 

February 6, 2003. For purposes of 

judicial review, this rule shall be 

promulgated at 1 p.m. eastern daylight/

standard time on January 21, 2003.

FOR FURTHER INFORMATION CONTACT: For 

general information contact: Barbara 

Cunningham, Acting Director, 

Environmental Assistance Division, 

Office of Pollution Prevention and 

Toxics (7401M), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460; 

telephone number: (202) 564–8170; e–

mail address: TSCA–Hotline@epa.gov. 

For technical information contact: 

Susan Sharkey, Project Manager, 

Economics, Exposure and Technology 

Division (7406M), Office of Pollution 

Prevention and Toxics, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460; 

telephone number: (202) 564–8789; e–

mail address: sharkey.susan@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information 

A. Does this Action Apply to Me? 

You may be affected by this action if 

you manufacture (defined by statute to 

include import) chemical substances 

currently subject to reporting under the 

Inventory Update Rule (IUR) at 40 CFR 

part 710 or if you manufacture inorganic 

chemical substances. Any use of the 

term ‘‘manufacture’’ in this document 

will encompass ‘‘import,’’ unless 

otherwise stated. In the past, persons 

that only are processors of chemical 

substances have not been required to 

comply with the requirements of 40 CFR 

part 710. These amendments do not 

change the status of processors under 

the regulations at 40 CFR part 710. 

Potentially affected categories and 

entities may include, but are not limited 

to: 

Chemical manufacturers and 

importers currently subject to IUR 

reporting, and chemical manufacturers 

and importers of inorganic chemical 

substances (NAICS codes 325, 32411). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. North American Industrial 

Classification System (NAICS) codes 

have been provided to assist you and 

others in determining whether this 

action applies to certain entities. To 

determine whether you or your business 

is affected by this action, you should 

carefully examine the applicability 

provisions in § 710.48 in the regulatory 

text. If you have any questions regarding 

the applicability of this action to a 

particular entity, consult the technical 

contact person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Copies of this 

Document or Other Related 

Information? 

1. Docket. EPA has established an 

official public docket for this action 

under docket ID number OPPT–2002–

0054. The official public docket consists 

of the documents specifically referenced 

in this action, any public comments 

received, and other information related 

to this action. Although a part of the 

official docket, the public docket does 

not include Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

The official public docket is the 

collection of materials that is available 

for public viewing at the EPA Docket 

Center, Rm. B102–Reading Room, EPA 

West, 1301 Constitution Ave., NW., 

Washington, DC. The EPA Docket 

Center is open from 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

legal holidays. The EPA Docket Center 

Reading Room telephone number is 

(202) 566–1744 and the telephone 

number for the OPPT Docket, which is 

located in EPA Docket Center, is (202) 

566–0280. 

2. Electronic access. You may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. An 

electronic version of the public docket 

is available through EPA’s electronic 

public docket and comment system, 

EPA Dockets. You may use EPA Dockets 

at http://www.epa.gov/edocket/ to view 

public comments, access the index 

listing of the contents of the official 

public docket, and access those 

documents in the public docket that are 

available electronically. Although not 

all docket materials may be available 

electronically, you may still access any 

of the publicly available docket 

materials through the docket facility 

identified in Unit I.B.1. Once in the 

system, select ‘‘search,’’ then key in the 

appropriate docket identification 

number. 

II. Background 

A. What Action is the Agency Taking? 

1. Substantive changes to the CFR. 

EPA is promulgating amendments to the 

IUR (IURA) which were proposed on 

August 26, 1999 (64 FR 46772) (FRL–

6097–4), taking into consideration 

comments received on the proposal. The 

amendments to the IUR that are 

contained in this final rule, as well as 

the inventory update provisions of 40 

CFR part 710 that are unchanged by 

these amendments, appear in a new 

subpart C to 40 CFR part 710. The 

inventory update provisions that apply 

to the 2002 update remain unchanged 

although the Agency has added subpart 

headings in order to distinguish the 

provisions that apply to the 2002 update 

(i.e., the existing IUR) and the new and 

revised provisions promulgated in this 

rule. The following is a brief listing of 

the primary changes to the IUR, which 

do not affect the regulations in place for 

IUR reporting in 2002. These changes 

are described in more detail in this 

document, along with a summary of the 

comments received and the Agency’s 

summary response to those comments. 

First, EPA is amending the existing 

IUR regulations, 40 CFR 710.28 and 

710.32, which appear in the new 

subpart C as §§ 710.48 and 710.52, to 

raise the production volume basic 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 849

reporting threshold from the current 

10,000 pounds (lbs.) per year to 25,000 

lbs. per year, and to add a new largervolume reporting threshold of 300,000 

lbs. per year for the reporting of 

processing and use information. 

Second, EPA is amending 40 CFR 

710.32, which appears in the new 

subpart C as § 710.52, to add exposure–

related information to the existing 

reporting requirements for chemical 

substances covered by the IUR. 

Specifically, the Agency is requiring 

that manufacturers subject to the 

amended rule (‘‘submitters’’) report, in 

ranges: (1) The number of workers 

reasonably likely to be exposed to the 

chemical substance at the site of 

manufacture; (2) the physical form(s) in 

which the chemical substance is sent 

off–site; (3) the percentage of total 

reported production volume associated 

with each physical form; and (4) the 

maximum concentration of the chemical 

substance at the time it leaves the 

submitter’s manufacturing site or, if the 

chemical substance is site–limited, the 

maximum concentration at the time it is 

reacted on–site to produce a different 

chemical substance. 

Third, EPA is amending 40 CFR 

710.32, which appears in the new 

subpart C as § 710.52, to require 

chemical manufacturers of chemical 

substances with production volumes of 

300,000 lbs. or greater to report certain 

exposure–related information 

concerning the processing and use of 

each reportable chemical substance that 

is conducted at sites that receive the 

reportable chemical substance from the 

submitter site directly or indirectly 

(whether the recipient site(s) are 

controlled by the submitter site or not) 

(including through a broker/distributor, 

from a customer of the submitter, etc.). 

Specifically, manufacturers of these 

larger–production volume chemical 

substances will be required to report, to 

the extent the information is readily 

obtainable: 

• The type of industrial processing 

or use operation(s) at each site, 

including downstream sites. 

• The five–digit NAICS codes that 

best describe the industrial activities 

during the processing or use operation. 

• The industrial function of each 

chemical substance during the 

processing or use operation, for each 

NAICS code reported. 

• The percentages of the submitter’s 

production volume used in each 

industrial function category. 

• The number of sites where the 

various processing or use operations 

occur. 

• The number of workers reasonably 

likely to be exposed to the chemical 

substance in each processing or use 

operation. 

• The categories of commercial and 

consumer uses of the reportable 

chemical substance. 

• An indication of the presence of 

the reportable chemical substance in or 

on consumer products intended for use 

by children. 

• The percentages of the submitter’s 

production volume associated with each 

commercial and consumer product 

category. 

• The maximum concentration of 

the reportable chemical substance in 

each commercial and consumer product 

category. 

Fourth, EPA is revoking the current 

full exemption from IUR reporting at 40 

CFR 710.26(a) for inorganic chemical 

substances, and is phasing in reporting 

for these substances, which appears in 

the new subpart C as § 710.46(b)(3). For 

the first submission period following 

promulgation of IURA (i.e., the 2006 

submission period), EPA is requiring 

partial reporting for these substances 

(i.e., inorganic chemical substances will 

not be subject to the reporting of 

processing and use information). In 

subsequent submission periods, 

manufacturers of an inorganic substance 

will be subject to full reporting (i.e., 

including the processing and use 

information reporting requirements), to 

the extent that they manufacture at least 

300,000 lbs. of the substance at a site 

during a given reporting year. 

Fifth, EPA is amending 40 CFR 

710.26, which appears in the new 

subpart C as § 710.46(b)(1), to create a 

partial reporting exemption for certain 

chemical substances termed ‘‘petroleum 

process streams’’ for purposes of 

reporting under the IURA (i.e., these 

chemical substances are not subject to 

the reporting of processing and use 

information). 

Sixth, EPA is providing, in 40 CFR 

710.46(b)(2), a partial exemption for 

specific chemical substances (i.e., these 

chemical substances are not subject to 

the reporting of processing and use 

information) where EPA has identified 

that there is a low current interest in the 

IURA processing and use information 

related to the chemical. EPA has 

identified a list of chemicals that are 

covered by this partial exemption, and 

provides a process for revising this list 

over time because interest in the IURA 

processing and use information for a 

particular chemical can change. 

Seventh, EPA is amending 40 CFR 

710.26, which appears in the new 

subpart C as § 710.46(a)(4), to provide a 

full exemption from IUR reporting for 

certain forms of natural gas. 

Eighth, EPA is amending 40 CFR 

710.32, which appears in the new 

subpart C as § 710.52, to require the 

reporting of more specific information 

to assist in the accurate identification of 

plant sites reporting under IUR. 

Ninth, EPA is amending 40 CFR 

710.28, 710.32, and 710.33, which 

appear in the new subpart C as 

§§ 710.48, 710.52, and 710.53, to change 

the period for which reporting is 

required from a corporate fiscal year to 

a calendar year basis. 

Tenth, EPA is amending 40 CFR 

710.32, which appears in the new 

subpart C as § 710.52, to allow 

submitters to claim their production 

volume range as CBI, in addition to the 

existing requirement that submitters 

report a specific production volume 

number and the CBI status of that 

specific number. Under the IURA, some 

submitters may choose to assert a 

confidentiality claim for specific 

production volume information while 

releasing the more general production 

volume range as public information. 

Eleventh, EPA is amending 40 CFR 

710.38, which appears in the new 

subpart C as § 710.58, to require 

substantiation of plant site 

confidentiality claims at the time such 

claims are made in IUR submissions to 

EPA (i.e., ‘‘upfront substantiation’’), in a 

manner similar to the upfront 

substantiation of chemical identity, 

which will continue to be required 

under 40 CFR 710.38, which appears in 

the new subpart C as § 710.58. 

Finally, EPA is amending 40 CFR 

710.37, which appears in the new 

subpart C as § 710.57, to extend the 

records retention period from 4 years to 

5 years. 

2. Technical changes to the CFR. The 

amendments that are contained in this 

final rule, as well as the parts of 40 CFR 

part 710 that are unchanged by these 

amendments, are codified in a new 

subpart C in 40 CFR part 710. Because 

promulgation of IURA will overlap a 

current IUR reporting cycle, EPA must 

maintain the existing IUR provisions in 

40 CFR part 710 in effect throughout the 

2002 submission period for the existing 

IUR. Submitters filing IUR reports in 

2002 must follow the regulations 

currently contained in 40 CFR part 710, 

which will now appear under the new 

heading as subpart B. On January 1, 

2003, the regulations in this final rule 

that are promulgated in subpart C of 40 

CFR part 710 will become effective for 

use by submitters filing IURA reports in 

2006 and beyond. (See § 710.1(b) of the 

regulatory text) Since the Agency has 

duplicated in subpart C those provisions 

from subpart B (i.e., the existing part 

710) that are unchanged by these 

850 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

amendments, once the current reporting 

cycle is complete, subpart B will no 

longer be applicable and the Agency 

will issue a technical amendment to 

remove it from the CFR. The creation of 

subparts in 40 CFR part 710 does not 

make any substantive changes other 

than those that have been presented in 

this final rule. 

Although there are no substantive 

changes to the provisions from existing 

40 CFR part 710 that have been 

incorporated into the new subpart C, the 

Agency has made minor technical 

corrections to those provisions, as well 

as technical changes to the existing 

provisions that now appear in subpart 

A. Specifically, the Agency is correcting 

several typographical errors that appear 

in the existing 40 CFR part 710, and is 

making other minor non–substantive 

edits to that text. These technical 

corrections include the following. (Note 

wherever a change is being made to a 

new regulatory text provision, a 

regulatory text citation to the 

corresponding existing 40 CFR part 710 

provision is provided in parentheses, 

e.g., § 710.59 (§ 710.39). This 

parenthesized citation is provided in 

order to identify where the new 

regulatory text originated.) 

In accordance with plain language 

principles, EPA has substituted ‘‘will’’

or ‘‘must’’ for ‘‘shall.’’ These three terms 

are considered to be equivalent, and 

delineate requirements to be followed or 

met. Corrections were made in the 

following sections: § 710.1(d) 

(§ 710.1(c)); § 710.3(a) (§ 710.2(a)); 

§ 710.3(b) (§ 710.2(b)); § 710.3(c) 

(§ 710.2(c)); § 710.3(d) in the definition 

for ‘‘Administrator’’ (§ 710.2(e)); 

§ 710.3(d) in the definition for ‘‘site’’

(§ 710.2(w)); § 710.3(d) in the note 

following the definition for ‘‘small 

quantities for research and 

development’’ (§ 710.2(y)); and 

§ 710.4(b)(2) (§ 710.4(b)(2)). 

EPA has corrected some punctuation 

and spelling errors: commas were added 

in § 710.1(a) (§ 710.1(a)), in § 710.3(d) in 

the definition for ‘‘distribute in 

commerce’’ (§ 710.2(j)) and in the 

definition for ‘‘small quantities for 

research and development’’ and in the 

note following the same definition 

(§ 710.2(y)); commas were removed in 

the definition for ‘‘distribute in 

commerce’’ (§ 710.2(j)) and in the note 

following the definition for ‘‘distribute 

in commerce’’ (§ 710.2(y)); in § 710.3(d) 

‘‘Process ‘for commercial purposes’’’

was substituted for ‘‘Process for 

‘commercial purposes’’’ in the 

definition for ‘‘Process ‘for commercial 

purposes’’’ ( § 710.2(u)); in § 710.3(d) 

‘‘juridical’’ was substituted for 

‘‘juridicial’’ in the definition for 

‘‘person’’ (§ 710.2(s)) and ‘‘appropriate’’

was substituted for ‘‘appropriated’’ in 

the definition for ‘‘technically qualified 

person’’ (§ 710.2(aa)(2)); in § 710.4(d)(2) 

‘‘premanufacture’’ was substituted for 

‘‘premanufacturing’’ (§ 710.4(d)(2)); and 

in § 710.4(d)(5) ‘‘photographic films’’

was substituted for ‘‘photographic, 

films’’ (§ 710.4(d)(5)). 

EPA has made certain additional non–

substantive changes. In § 710.3(d), EPA 

substituted ‘‘1,000 lbs. (454 kg)’’ for 

‘‘1,000 pounds’’ in the note following 

the definition for ‘‘small quantities for 

research and development’’ (§ 710.2(y)). 

EPA has substituted ‘‘his/her’’ for ‘‘his’’

in sections where the word ‘‘his’’ was 

used: in two instances in § 710.3(d) in 

the definition for ‘‘Administrator’’

(§ 710.2(e)); in § 710.3(d) in the 

definition for importer (§ 710.2(l)(2)); 

and in § 710.3(d) in the definition for 

‘‘technically qualified person’’

(§ 710.2(aa)). 

EPA has made certain additional nonsubstantive changes and updated 

information submission information in 

§ 710.59 by substituting ‘‘Availability of 

reporting form and instructions’’ for 

‘‘How do I submit the required 

information for the 1998 reporting 

cycle?’’ (§ 710.39); in § 710.59(a) by 

substituting ‘‘http://www.epa.gov/oppt/

iur’’ for ‘‘http://www.epa.gov/opptintr/

iur98’’ and by removing ‘‘or Fax-onDemand by using a faxphone to call 

(202) 401–0527 and selecting item 

5119’’ as Fax-on-Demand is no longer 

available (§ 710.39(a)); in § 710.59(b) by 

substituting ‘‘Guidance for completing 

the reporting form and preparing an 

electronic (magnetic media) report will 

be made available prior to each 

submission period.’’ for the existing 

paragraph after the heading 

(§ 710.39(b)); in § 710.59(c) by 

substituting ‘‘will send’’ for ‘‘is mailing’’

and ‘‘reporting package (consisting of a 

copy of Form U and a copy of the 

reporting instructions) to those 

submitters that reported in the IUR 

submission period that occurred 

immediately prior to the current 

submission period.’’ for ‘‘reporting 

package to those companies that 

reported in 1994. ’’ (§ 710.39(c)); in 

§ 710.59(c)(1), EPA substituted ‘‘By 

telephone’’ for ‘‘By phone’’ and 

removed ‘‘or TDD 202–554–0551’’ as the 

TDD number is no longer available 

(§ 710.39(c)(1)); in § 710.59(c)(2), EPA 

substituted ‘‘TSCA-Hotline@epa.gov’’

for ‘‘TSCA-Hotline@epamail.epa.gov’’

(§ 710.39(c)(2)); and in § 710.59(c) and 

(d) EPA substituted ‘‘7408M’’ for 

‘‘7408,’’ ‘‘OPPT Document Control 

Officer (DCO)’’ for ‘‘Document Control 

Officer,’’ and ‘‘Environmental Protection 

Agency’’ for ‘‘U.S. Environmental 

Protection Agency’’ (§ 710.39(c)(3)); and 

by adding § 710.59(c)(4) to state that the 

reporting form and instructions will 

additionally be available via the 

Internet. 

EPA has also made minor technical 

corrections to the existing provisions in 

§ 710.39 that now appear in subpart B. 

EPA removed ‘‘for the 1998 reporting 

cycle’’ from the section heading to 

clarify that the section applies to the 

current reporting cycle. In § 710.39(a), 

EPA replaced the website address with 

the current address, www.epa.gov/oppt/

iur/iur02/index.htm, and removed the 

Fax-on-Demand information, which is 

no longer available. In § 710.39(c)(1), 

EPA removed the TDD number, which 

is no longer available. The Agency 

corrected dates and addresses in 

§ 710.39(c), (c)(3), and (d) by replacing 

‘‘1994’’ with ‘‘1998,’’ ‘‘Mail Code 7408’’

with ‘‘Mail Code 7408M,’’ and inserting 

‘‘OPPT’’ before ‘‘Document Control 

Officer.’’

EPA made minor revisions to clarify 

the meaning of certain provisions. In 

§ 710.1(a) ‘‘and recordkeeping’’ was 

inserted after ‘‘governing reporting,’’

‘‘(TSCA)’’ was inserted after ‘‘(15 U.S.C. 

2607(a)),’’ and ‘‘and keeping current’’

was inserted after ‘‘purpose of 

compiling’’ (§ 710.1(a)); in § 710.1(d), 

the note following the paragraph was 

added to the end of the paragraph and 

‘‘Note: As a matter of traditional Agency 

policy,’’ was removed (§ 710.1(b)); in 

§ 710.52(c)(1) ‘‘submitter’’ was 

substituted for ‘‘respondent’’ and ‘‘as 

described in § 710.59’’ for ‘‘from EPA at 

the address set forth in § 710.39’’

(§ 710.32(c)(1)); in § 710.52(c)3(ii) 

‘‘indicating, for each reportable 

chemical substance at each site,’’ was 

substituted for ‘‘for each substance for 

which information is being submitted 

indicating’’ and added ‘‘, or both 

manufactured in the United States and 

imported in the United States’’

(§ 710.32(c)(5)); in § 710.52(c)(3)(iii) 

‘‘designation indicating, for each 

reportable chemical substance at each 

site,’’ was substituted for ‘‘statement for 

each substance for which information is 

being submitted indicating’’

(§ 710.32(c)(6)); in §§ 710.45 and 

710.55(a) ‘‘submission period’’ was 

substituted for ‘‘reporting period’’

(§§ 710.25 and 710.35(a)); in § 710.48 

‘‘section’’ was substituted for ‘‘§ 710.28’’

(§ 710.28); in § 710.48(b) ‘‘paragraphs (a) 

and (b)’’ were deleted (§ 710.28(c)); in 

§ 710.52(c)(3)(iv) ‘‘reportable’’ was 

substituted for ‘‘subject’’ (§ 710.32(c)(7)); 

in § 710.58(b) ‘‘Chemical identity.’’ was 

added as a section header to more 

clearly identify the topic of the section, 

and ‘‘The following steps must be taken 

to assert’’ was substituted for ‘‘To 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 851

assert,’’ and ‘‘reportable’’ was 

substituted for ‘‘specific’’ (§ 710.38(c)(b) 

and (c)); in § 710.58(b)(1) ‘‘submitter’’

was substituted for ‘‘person’’

(§ 710.38(c)(1)); in § 710.58(b)(1)(i) 

‘‘subpart’’ was substituted for ‘‘part’’

(§ 710.58(c)(1)(i)); in § 710.58(b)(1)(vi) 

substituted ‘‘have been taken’’ for ‘‘have 

you taken’’ and ‘‘the’’ for ‘‘this’’

(§ 710.38(c)(1)(vi)); in § 710.58(c)(2) 

‘‘listed in paragraph (c)(1) of this 

section’’ was added for clarification 

purposes, ‘‘submitter’’ was substituted 

for ‘‘person’’ and ‘‘clearly identify the 

information that is claimed confidential 

by marking the specific information on 

each page with a label such as 

‘confidential business information,’

‘proprietary,’ or ‘trade secret.’’’ was 

substituted for ‘‘mark that information 

as ‘trade secret,’ ‘confidential,’ or other 

appropriate designation.’’

(§ 710.38(c)(2)); and in § 710.58(d) ‘‘is 

indicated on the reporting form’’ was 

substituted for ‘‘accompanies 

information at the time it is’’ and 

‘‘confidentiality claim substantiation’’

was substituted for ‘‘substantiation’’

(§ 710.38(d)). 

EPA replaced ‘‘manufactured or 

imported’’ with ‘‘manufactured 

(including imported)’’ to provide 

consistency and clarification. EPA made 

this change in: § 710.52(c)(3)(iv) 

(§ 710.32(c)(7)); § 710.58(c)(1)(v) 

(§ 710.38(c)(1)(v)); § 710.58(c)(1)(vi) 

(§ 710.38(c)(1)(vi)); § 710.58(c)(1)(vii) 

(§ 710.38(c)(1)(vii)); § 710.58(c)(1)(viii) 

(§ 710.38(c)(1)(viii)); § 710.58(c)(1)(x) 

(§ 710.38(c)(1)(x)); and § 710.48 

(§ 710.28). 

EPA moved three definitions that 

currently appear in § 710.2 to § 710.23, 

to clarify that they apply to the existing 

IUR. In § 710.3(d), three changes were 

made in recognition that the definitions 

are no longer separated into sections, 

but are contained within paragraph (d): 

in the § 710.3(d) definition for 

‘‘Commerce,’’ ‘‘paragraph (1) of this 

definition’’ was substituted for 

‘‘paragraph (1) of this section’’

(§ 710.2(i)), and in the § 710.3(d) 

definition for ‘‘Technically qualified 

individual,’’ ‘‘this paragraph’’ was 

substituted for ‘‘paragraph (aa)(3) of this 

section’’ and ‘‘paragraph (1) of this 

definition’’ was substituted for 

‘‘paragraph (aa)(1) of this section’’

(§ 710.2(aa)(3)). 

Section 553 of the Administrative 

Procedure Act (APA), 5 U.S.C. 

553(b)(B), provides that, when an 

agency for good cause finds that notice 

and public procedure are impracticable, 

unnecessary or contrary to the public 

interest, the agency may promulgate a 

rule without providing notice and an 

opportunity for public comment. EPA 

has determined that there is good cause 

for making these minor regulatory 

changes in this final rule without prior 

notice and opportunity for comment 

because these minor corrections are 

non–substantive and do not affect the 

meaning or legal effect of the provisions 

affected, which remains the same as it 

was when the provision appeared in 40 

CFR part 710. Thus, notice and public 

procedure are unnecessary for these 

minor changes to the existing or new 

provisions in 40 CFR part 710. EPA 

finds that this constitutes good cause 

under 5 U.S.C. 553(b)(B). 

B. What is the Agency’s Authority for 

Taking this Action? 

EPA is required under TSCA section 

8(b), 15 U.S.C. 2607(b), to compile and 

keep current an inventory of chemical 

substances in commerce. This inventory 

is known as the TSCA Chemical 

Substances Inventory (the TSCA 

Inventory). In 1977, EPA promulgated a 

rule (42 FR 64572, December 23, 1977) 

under TSCA section 8(a), 15 U.S.C. 

2607(a), to compile an inventory of 

chemical substances in commerce at 

that time. In 1986, EPA promulgated the 

initial IUR at 40 CFR part 710 (51 FR 

21447, June 12, 1986), also under TSCA 

section 8(a), to facilitate the periodic 

updating of the TSCA Inventory and to 

support activities associated with the 

implementation of TSCA. 

TSCA section 8(a)(1) authorizes the 

EPA Administrator to promulgate rules 

under which manufacturers and 

processors of chemical substances and 

mixtures (referred to hereinafter as 

‘‘chemical substances’’) must maintain 

such records and submit such 

information as the Administrator may 

reasonably require. Under TSCA section 

8(a), the Agency may collect 

information associated with chemical 

substances to the extent that it is known 

to or reasonably ascertainable by the 

submitter. TSCA section 8(a) gives EPA 

broad discretion in determining the 

information for which reporting can be 

required. Some of the types of 

information which can be required 

under TSCA section 8(a)(2) include: 

Categories of use for each chemical 

substance; estimates of the amount 

manufactured or processed for each 

category of use; a description of the 

byproducts resulting from the 

manufacture, processing, use, or 

disposal of each chemical substance; an 

estimate of the number of individuals 

exposed in their places of employment; 

and the duration of such exposure. 

TSCA section 8(a) generally excludes 

small manufacturers and processors of 

chemical substances from the reporting 

requirements established in TSCA 

section 8(a). However, EPA is 

authorized by TSCA section 8(a)(3) to 

require TSCA section 8(a) reporting 

from small manufacturers and 

processors with respect to any chemical 

substance that is the subject of a rule 

proposed or promulgated under TSCA 

section 4, 5(b)(4), or 6, or that is the 

subject of an order under TSCA section 

5(e), or that is the subject of relief that 

has been granted pursuant to a civil 

action under TSCA section 5 or 7. The 

standard for determining whether an 

entity qualifies as a ‘‘small 

manufacturer’’ for purposes of 40 CFR 

710.29, and for 40 CFR part 710 

generally, is defined in 40 CFR 704.3. 

Processors are not currently subject to 

the regulations at 40 CFR part 710. 

This document promulgates the IURA 

as subpart C in 40 CFR part 710, which 

includes provisions copied from the 

existing IUR regulations in 40 CFR part 

710 that are not substantively changed 

as a part of this rulemaking, and the 

new IURA provisions in this final rule. 

Failure to comply fully with any 

provision of this final rule will be a 

violation of TSCA section 15 and will 

subject the violator to the penalties of 

TSCA sections 16 and 17. 

C. What is the Inventory Update Rule 

(IUR)? 

The IUR requires U.S. manufacturers 

of organic chemicals to report to EPA 

every 4 years the identity of chemical 

substances manufactured annually 

during the reporting year in quantities 

of 10,000 lbs. or more at each plant site 

they own or control. The current IUR 

generally excludes several categories of 

substances from its reporting 

requirements, i.e., polymers, inorganic 

substances, microorganisms, and 

naturally occurring chemical 

substances. Plant sites subject to the 

rule are currently required to report 

information such as company name, 

plant site location, plant site Dun and 

Bradstreet number(s), identity of the 

reportable chemical substance, and 

production volume of each reportable 

chemical substance. Data were reported 

to EPA under the IUR in 1986, 1990, 

1994, and 1998, and a collection is 

occurring in 2002. 

The data reported under IUR are used 

to update the information maintained 

on the TSCA Inventory, which is a 

listing of chemical substances in 

commerce. EPA uses the TSCA 

Inventory and data reported under the 

IUR to support many TSCA-related 

activities and to provide overall support 

for a number of EPA and other Federal 

health, safety, and environmental 

protection activities (See Unit II.E. for 

852 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

further explanation of some of these 

activities). 

D. Why is EPA amending the IUR? 

EPA is amending the IUR for three 

primary reasons: (1) To tailor the 

chemical substance reporting 

requirements to more closely match the 

Agency’s information needs; (2) to 

obtain new and updated information 

relating to potential exposures to a 

subset of chemical substances listed on 

the TSCA Inventory; and (3) to improve 

the utility of the information reported. 

These amendments will enhance the 

information collected through the IUR, 

improve the scope of chemicals covered 

by the rule, and improve CBI claims, 

thereby accomplishing these three goals. 

These goals are supported by the 

policy in section 2(b)(1) of TSCA, that 

‘‘adequate data should be developed 

with respect to the effect of chemical 

substances and mixtures on health and 

the environment and that the 

development of such data should be the 

responsibility of those who manufacture 

and those who process such chemical 

substances and mixtures.’’ The data 

currently available to EPA are generally 

inadequate for risk screening purposes. 

TSCA section 8(a)(2) authorizes EPA to 

require manufacturers and processors of 

chemical substances to report a wide 

variety of data, including exposure–

related information which will be 

reported for certain chemical substances 

under IURA. These amendments remove 

certain reporting requirements and add 

others to focus reporting under the IUR 

on that information which is most 

needed by EPA and other Federal 

agencies for screening, assessing, and 

managing risk. Additionally, the 

availability of these data will enhance 

public awareness of basic information 

about chemical substances. 

Any evaluation of potential ‘‘risk’’ is 

generally based on a combination of 

hazard information and exposure 

information. EPA relies on risk 

screening to indicate which chemical 

substances pose a potential risk to 

human health or the environment, and 

thus warrant a more detailed, resource 

intensive analysis. The EPA Science 

Advisory Board’s report ‘‘Reducing 

Risk: Setting Priorities and Strategies for 

Environmental Protection’’ (Ref. 1) and 

the National Academy of Public 

Administration’s report ‘‘Setting 

Priorities, Getting Results, A New 

Direction for EPA’’ (Ref. 2) recognize 

that EPA’s ability to use risk screening 

to set priorities and allocate its limited 

resources has been significantly 

impeded by a lack of exposure data. The 

manufacturing, processing, and use of 

chemicals on the TSCA Inventory result 

in a wide array of exposure scenarios. 

The exposure-related data included in 

IURA will greatly improve EPA’s ability 

to conduct risk screening to identify 

chemical substances that could pose an 

unreasonable risk to human health or to 

the environment, or that otherwise 

warrant further investigation. 

E. What are EPA’s TSCA-Related 

Chemical Screening and Assessment 

Activities? 

TSCA authorizes EPA to gather 

chemical hazard and exposure data, as 

well as related information such as 

production volume, to determine 

whether a chemical may pose an 

unreasonable risk of injury to human 

health or the environment. The Agency 

is able to institute risk management 

actions when necessary to mitigate or 

avoid unreasonable risk. Important 

elements in a successful chemical risk 

management program include 

identifying the chemical substances, 

manufacturing sites, and exposure 

scenarios of greatest potential concern, 

and using that information to set 

priorities for more detailed risk 

assessment, further research, advisory 

notices, or other appropriate actions. To 

help fulfill its TSCA responsibilities, 

EPA has established the IUR and other 

regulations to collect information on 

commercial chemicals. 

The TSCA Inventory currently 

includes more than 76,000 chemical 

substances. Approximately 8,900 of 

these chemical substances are nonpolymer, organic chemical substances 

manufactured at at least one site in 

quantities of 10,000 lbs. or more per 

year, as reported under the 1998 IUR 

data collection. EPA estimates that 

IURA will continue to collect 

information on approximately 8,900 

chemical substances. However, the set 

of substances that will be reported 

under IURA will be somewhat different 

than the set of substances that was 

reported under the previous IUR 

collections primarily because of two 

changes: Raising the basic reporting 

threshold (see Unit II.F.2.) and adding 

reporting on the manufacture of 

inorganic chemical substances (see Unit 

II.F.1.a.). Data collected under IURA 

will enable EPA to more effectively 

conduct initial risk screening on a 

subset of the chemical substances 

within its purview, as described in the 

remaining part of this section and in 

Unit III.A.1. 

EPA conducted tiered risk evaluations 

of chemical substances even prior to the 

enactment of TSCA in 1976. A tiered 

approach allows EPA to sort through 

many chemicals, focus on those 

chemical substances of greatest concern, 

and take appropriate actions. The 

Agency is thus able to optimize 

resources while limiting overall 

regulatory burdens. The essential steps 

of the tiered risk evaluation generally 

include: An initial evaluation 

(sometimes preceded by a prescreen of 

candidate chemicals); basic risk 

management decisions resulting from 

the initial screening; more detailed risk 

assessment when appropriate; and 

resulting risk management actions, such 

as regulatory or voluntary efforts to 

reduce risk. Each of these steps is only 

as effective as the available data inputs-

-if little data exist to inform the process, 

each step suffers as a result. 

Exposure-related information 

collected through the IURA will inform 

the initial risk screening step. Initial risk 

screening is conducted using readily 

accessible information from the 

scientific literature, as well as other data 

readily available to the Agency, such as 

those provided by manufacturers and 

processors. This information set often is 

incomplete or of insufficient quality to 

allow the Agency to reach definitive 

conclusions about the set of chemicals 

under review, but may be sufficient to 

decide which chemicals appear to 

warrant further evaluation, or 

conversely, appear to be low priority 

and therefore do not currently warrant 

further review. These initial reviews are 

often more qualitative than quantitative. 

Also, continual updates to these data, 

such as the recurring reporting of 

exposure-related data under IURA, will 

ensure that the most serious concerns 

will be addressed even as chemical 

quantities and exposure potentials 

change between submission periods. 

The effectiveness of risk screening, 

risk assessment, and risk management is 

dependent upon the quality as well as 

the availability of both hazard and 

exposure information. While past 

approaches to priority setting have 

emphasized relative chemical hazards 

and used production volume as a simple 

surrogate for exposure, EPA must 

increase its emphasis on the exposure 

component of risk screening and 

assessment. EPA no longer believes that 

reporting under the current IUR is 

adequate for these purposes. The IURA 

will provide EPA with data that will 

more accurately and realistically gauge 

potential exposures. The exposurerelated information reported under 

IURA will be used in combination with 

hazard information developed under 

TSCA section 4 test rules and 

enforceable consent agreements/orders, 

through voluntary efforts such as the 

High Production Volume (HPV) 

Challenge Program (see www.epa.gov/

opptintr/chemrtk/volchall.htm), and 

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other sources. These more current and 

complete data from the IURA will allow 

the Agency and others to screen and 

prioritize chemicals based on potential 

risk more effectively than it is currently 

able to do. 

Although the inherent hazard 

associated with a chemical substance 

will generally remain the same over 

time, exposure of workers and affected 

populations can change significantly. If 

the amount of a chemical substance 

produced increases significantly, 

releases to the environment and human 

exposures would also be expected to 

increase. Conversely, if the amount 

produced remains constant, 

environmental releases and human 

exposures may decline as engineering 

controls are added and pollution 

prevention practices are implemented. 

Although the hazard associated with a 

chemical generally remains constant, 

the risk associated with the 

manufacturing, processing, and use of a 

chemical substance will change as 

exposure increases or changes. The 

Agency needs to be able to identify 

changes in exposures as well as specific 

exposure scenarios, making it important 

to collect exposure data on a regular 

basis. Chemicals that present low 

hazard may still pose a risk if they are 

produced in large amounts and have 

high exposure potential, are released 

into the environment at high volumes 

and/or concentrations, or involve 

exposures to particularly sensitive 

subpopulations. 

A voluntary effort called the Use and 

Exposure Information Project (UEIP) 

demonstrated that useful screening level 

exposure information is available to and 

can be reported by industry. The UEIP 

was a cooperative effort begun in the fall 

of 1992 between government and 

industry in recognition of the 

difficulties encountered in obtaining 

accurate and up-to-date exposure 

information on HPV TSCA chemicals. 

Participants included EPA, the 

Chemical Manufacturers Association 

(CMA) (now the American Chemistry 

Council, or ACC), the Chemical 

Specialty Manufacturers Association 

(CSMA), the Synthetic Organic 

Chemical Manufacturers Association 

(SOCMA), and the American Petroleum 

Institute (API) (Ref. 3). Data collected by 

EPA under the UEIP were similar to 

those now being required under IURA, 

and included the following: Production 

volume, site location, percentage of 

production volume for a given use, 

environmental releases, number of 

workers, worker activities, monitoring 

data, and industrial and consumer uses. 

EPA’s experience with UEIP has shown 

that the types of data requested by the 

UEIP are available from industry and 

can be used to prepare screening level 

exposure assessments. 

The UEIP, however, provided onetime reporting of information by a 

subset of the manufacturers of a small 

number of selected HPV chemicals. 

Given these efforts, the limitations of 

the data available from past and current 

information collections that are 

described in detail in the proposal for 

these amendments (64 FR 46772, 

August 26, 1999), and the amount of 

time it would otherwise take to acquire 

screening level exposure data for the 

chemical substances on the TSCA 

Inventory, it is appropriate to develop a 

more systematic and broadly applied 

approach to the prioritization process. 

The Agency is doing this by requiring 

that certain basic exposure-related 

information be reported under this 

amended rule instead of collecting the 

information through a one-time 

voluntary program. 

F. What Are the Requirements of IURA? 

The regulatory text of this document 

describes the specific IURA reporting 

requirements. EPA is also developing a 

guidance document with specific 

reporting instructions, and intends to 

conduct workshops to help potential 

IURA submitters become familiar with 

the revised reporting form (Form U) and 

amended reporting requirements. A 

draft version of the revised Form U is 

available in the docket, and EPA intends 

to develop an electronic version of the 

revised Form U. EPA will seek 

additional feedback on the revised 

form’s structure, format, and layout 

before finalizing it for use in 2006. 

Submitters should note that the 

information in § 710.52(c)(1) and (c)(2) 

of the regulatory text (Part I of the 

revised Form U) need only be reported 

once per reporting cycle for each 

submitter site manufacturing 25,000 lbs. 

or more of a reportable chemical, while 

the information in § 710.52(c)(3) and 

(c)(4) of the regulatory text (Parts II and 

III of the revised Form U, respectively) 

will be reported for each reportable 

chemical at a reporting site, depending 

upon the chemical’s production volume. 

1. What are the changes to the 

chemical substances covered by IUR?—

a. Inorganic chemical substances. EPA 

is requiring partial reporting for 

inorganic chemical substances for 

reporting year 2005 information 

submitted to EPA during the 2006 

submission period, and full reporting 

for inorganic chemical substances in 

subsequent submission periods (see 

§ 710.46(b)(3) of the regulatory text). 

Partial reporting means that the 

submitter must report the information 

described in § 710.52(c)(1), (c)(2), and 

(c)(3), as well as §710.58 of the 

regulatory text, as applicable (i.e., Parts 

I and II of revised Form U.). Full 

reporting means that the submitter must 

additionally report the processing and 

use information as described in 

§ 710.52(c)(4) of the regulatory text (i.e., 

all parts of revised Form U). 

EPA intends to screen potential risks 

associated with inorganic chemical 

substances to set priorities for testing, 

more detailed risk assessment and 

potential risk management. The 

phasing-in of inorganic chemical 

reporting provides manufacturers of 

these chemicals with the opportunity to 

familiarize themselves with IUR 

reporting while providing EPA and 

others with needed basic manufacturing 

information on inorganic chemicals. 

Future full reporting of exposure-related 

information will provide EPA and 

others with needed additional 

information for those inorganic 

chemicals with production volumes of 

300,000 lbs. or more at a site. See Unit 

III.A.1. for a discussion of the 

importance of this exposure-related 

information to EPA and others for both 

organic and inorganic chemicals. Unit 

III.C.1.a. contains a discussion specific 

to inorganic chemicals. The basic 

impetus for collecting information on 

organic chemicals also holds for 

inorganic chemicals. 

b. Petroleum process streams. EPA is 

exempting certain chemical substances, 

termed ‘‘petroleum process streams’’ for 

purposes of IURA, from reporting the 

processing and use data contained in 

the regulatory text at § 710.52(c)(4). For 

purposes of this rule, the petroleum 

process streams included in the 

exemption are the multi-component 

complex chemical substances listed by 

Chemical Abstracts Service (CAS) 

Registry Number in the regulatory text 

at § 710.46(b)(1). This list of chemical 

substances was derived from the 1983 

publication of the API entitled 

‘‘Petroleum Process Stream Terms 

Included in the Chemical Substances 

Inventory Under the Toxic Substances 

Control Act (TSCA)’’ (Ref. 4). Chemical 

substances listed in the API document 

consisting of a single component 

chemical, except for water, will not be 

considered petroleum process streams 

for IURA reporting purposes. Water 

(CAS number 7732–18–5) is partially 

exempt from IURA reporting under the 

petroleum process stream exemption. 

The basis for this exemption is not 

because these streams are of known low 

toxicity. EPA believes that the 

chemicals termed ‘‘petroleum process 

streams’’ for purposes of IURA are often 

toxicologically active. However, these 

854 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

chemicals are frequently processed at 

the site where they are produced in 

vessels which are designed to minimize 

losses and, coincidentally, the potential 

for releases and exposure. In many 

cases, the flammable nature of these 

products requires that they also be 

transported, processed, and stored in 

well controlled vessels. For these 

reasons, EPA believes worker exposure 

to the chemicals termed ‘‘petroleum 

process streams’’ for purposes of IURA 

is diminished and thus full IURA 

exposure-related reporting is not 

warranted at this time. Partial IURA 

reporting includes site location and 

production volume information which 

have important uses by EPA and others 

apart from gauging exposures and risk 

screening. EPA may take action to 

revoke this exemption if circumstances 

warrant. 

In the final rule, EPA is making 

selected changes to the partial 

exemption list of petroleum process 

stream chemicals published in the 

proposed rule. Certain chemicals are 

being added to the list because they 

were inadvertently left off the proposed 

list covered by the exemption. These 

multi–component chemicals, all of 

which are listed in the 1983 API 

publication (Ref. 4), include the 

following chemical substances (CAS 

numbers): 8052–41–3, 64742–21–8, 

64742–26–3, 64742–94–5, 68476–32–4, 

68515–29–7, 68783–12–0, 68918–98–9, 

68919– 15–3, 68953–80–0, and 70693–

06–0. 

In the final rule, EPA is also removing 

a number of chemicals from the 

petroleum process stream partial 

exemption list published in the 

proposed rule. These chemicals fall into 

three groups: 

(1) Certain chemicals that are already 

part of the broader natural gas or 

polymer exemptions. Those already 

exempted under the natural gas 

exemption are: 8006–14–2, 8006–61–9, 

64741–48–6, 68410–63–9, 68425–31–0, 

and 68919–39–1. Additionally, an 

incorrect CAS number 68425–31–1 was 

corrected to read 68425–31–0, which, 

again, has been removed from the 

partial exemption because it is already 

fully exempt from IUR reporting under 

the natural gas exemption. Chemicals 

removed because they are already fully 

exempt under the polymer exemption 

are: 64741–71–5, 64741–72–6, 67891–

77–4, 67891–78–5, 68131–77–1, 68131–

79–3, 68131–80–6, 68131–81–7, 68131–

83–9, 68131–99–7, 68132–00–3, 68410–

01–5, 68410–10–6, 68410–13–9, 68410–

14–0, 68410–16–2, 68410–59–3, 68425–

27–4, 68425–28–5, 68476–87–9, 68477–

37–2, 68477–43–0, 68477–45–2, 68477–

46–3, 68477–50–9, 68477–51–0, 68477–

52–1, 68478–07–9, 68478–09–1, 68527–

24–2, 68527–25–3, 68783–10–8, 68783–

11–9, and 68955–30–6. 

(2) Single component chemicals, 

except for water, should not have been 

included in the petroleum process 

streams partial exemption. As stated in 

the proposed rule, the exemption was 

intended to include only certain multi–

component chemicals derived from the 

1983 API publication (Ref. 4). As a 

result, the following single–component 

chemicals have been removed from the 

petroleum process streams partial 

exemption list as proposed: 8007–45–2 

and 10024–97–2. 

(3) Certain chemicals that are not 

included on the TSCA Inventory and 

therefore are not currently reportable 

under IUR have also been removed from 

the exemption list: 64741–93–1, 64741–

94–2, 64742–00– 3, 64742–02–5, 64742–

17–2, 64742–66–1, 64742–74–1, 64742–

84–3, and 64754–96–7. 

In this final rule, EPA is also making 

some additional corrections to the 

petroleum process streams partial 

exemption list published in the 

proposed rule. 

(1) Incorrect CAS numbers for certain 

chemicals were provided in the 

proposed rule. These CAS numbers 

were incorrect because of typographical 

errors in the proposed rule. The correct 

CAS numbers (incorrect CAS numbers 

are in parentheses) are as follows: 8006–

20–0 (8006–20–2), 64742–18–3 (64742–

18–2), 64742–20–7 (64742–20–3), 

68187–60–0 (68187–60–9), 68459–78–9 

(68459–79–8), 68513–14–4 (68514–14–

4), 68513–19–9 (68512–19–9), and 

68514–38–5 (68514–38–4). Two 

additional incorrect CAS numbers were 

provided in the proposed rule, i.e., 

64742–36–2 and 68741–41–9. The 

corrected CAS numbers for these 

chemicals, i.e., 64742–36–5 and 64741–

41–9 respectively, were also provided in 

the proposed rule. 

(2) Several duplicate CAS numbers 

that were included in the proposed rule 

have been removed. 

(3) CAS numbers for certain 

chemicals have been superceded by new 

CAS numbers. The new CAS numbers 

are as follows (superceded CAS 

numbers are in parenthesis): 68187–58–

6 (68334–31–6), 68410–13–9 (68477–

56–5), 68308–08–7 (68478–21–7), 

68334–30–5 (68512–90–3), 68918–99–0 

(68513–26–8), 64742–83–2 (6851–30–7), 

68988–79–4 (68515–31–1), 64742–93–4 

(68516–21–2), 68606–10–0 (68606–35–

9), and 64742–93–4 (68650–78–2). 

c. Natural gas. EPA is exempting 

certain forms of natural gas from IUR 

reporting. These substances are listed in 

the regulatory text at § 710.46(a)(4). EPA 

believes that, to date, adequate IUR 

information has been collected on these 

chemical substances to fulfill EPA’s and 

other IUR information users’ current 

needs. EPA will take action to revoke 

this exemption if circumstances warrant 

in the future. 

d. Specific chemical substances. EPA 

is exempting certain specific chemical 

substances for which EPA has 

determined that there is a low current 

interest in the IURA processing and use 

information from reporting the 

processing and use information 

contained in the regulatory text at 

§ 710.52(c)(4). These chemicals are still 

subject to the other requirements of 

IURA. The chemical substances 

included in this partial exemption are 

listed by CAS Number in the regulatory 

text at § 710.46(b)(2)(iv). EPA is also 

establishing a process for revising the 

list of exempted chemical substances 

over time. 

EPA is establishing this partial 

exemption in an effort to improve 

IURA’s efficiency and effectiveness. 

This partial exemption also provides 

additional benefits in reducing the 

potential reporting burden of IURA for 

certain manufacturers of these 

chemicals, and provides an efficient 

process for amending the partial 

exemption list as the need for 

processing and use information under 

IURA changes over time. The inclusion 

of a chemical substance under this 

partial exemption is not based on the 

potential risks of a chemical. This 

partial exemption is solely intended to 

provide a tool to assist the Agency in 

better managing the collection of 

processing and use information under 

IURA. 

In the proposed rule, EPA specifically 

sought comment on a partial reporting 

exemption for ‘‘low priority’’ chemicals, 

and requested comment on the criteria 

the Agency might use to establish such 

an exemption, as well as the specific 

chemicals that might qualify for such an 

exemption. (See Unit IX.3. of the 

preamble to the proposal, at 64 FR 

46794). EPA also offered several 

approaches for identifying the 

chemicals that could be considered for 

such an exemption. A number of 

commenters supported the creation of a 

partial exemption, and several provided 

suggestions for additional chemical 

substances or classes of substances that 

they wanted EPA to consider including 

in this or an expanded partial 

exemption. 

In response to the comments received, 

EPA has established a partial exemption 

that applies when EPA has determined 

that there is a low current interest in the 

chemical’s IURA processing and use 

information. Because IURA reporting is 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 855

chemical-specific, this exemption 

applies to the specific chemical 

substances that are listed within the 

exemption, which are discussed in more 

detail below. The need for EPA’s 

collection of IURA processing and use 

information related to a particular 

chemical substance can change over 

time; therefore, EPA has also established 

a process that will allow EPA to revise 

the list by adding or removing a 

chemical to reflect the change in 

interest. The process allows anyone to 

submit a written request for EPA to 

consider revising the list of chemical 

substances covered under this partial 

exemption. EPA may also revise the list 

on its own initiative. When a list 

revision is necessary, EPA’s preferred 

approach will be to issue a direct final 

rule, which affords an opportunity for 

public comment, while providing an 

efficient mechanism for revising the list. 

In determining whether there is low 

current interest in IURA processing and 

use information related to a specific 

chemical substance, EPA will look to 

the specific circumstances surrounding 

the chemical in question, and may use 

one or more of the considerations 

identified below, and/or considerations 

not identified below, to make an 

informed decision. EPA will consider 

the totality of information available for 

the chemical substance, including but 

not limited to the following: 

(A) Whether the chemical qualifies or 

has qualified in past IUR collections for 

the reporting of the information 

described in § 710.52(c)(4) (i.e., at least 

one site manufactures 300,000 pounds 

or more of the chemical). 

(B) The chemical substance’s 

chemical and physical properties or 

potential for persistence, 

bioaccumulation, health effects, or 

environmental effects (considered 

independently or together). 

(C) The information needs of EPA, 

other federal agencies, tribes, states, and 

local governments, as well as members 

of the public. 

(D) The availability of other 

complementary risk screening 

information. 

(E) The availability of comparable 

processing and use information. 

(F) Whether the potential risks of the 

chemical substance are adequately 

managed by EPA or another agency or 

authority. 

It is important to note that the inclusion 

of these chemical substances under this 

partial exemption is not based on the 

potential risks of the chemicals, but is 

based on the Agency’s current 

assessment of the need for collecting 

IURA processing and use information. 

Additionally, some of these chemicals 

have issues that may renew interest in 

them in the future, at which time EPA 

will reconsider the applicability of this 

partial exemption for those chemicals. 

To create an initial list of specific 

chemical substances covered by this 

partial exemption, EPA started with: 

(1) The list of chemical substances 

identified as part of the HPV Challenge 

Program for which, based upon a 

preliminary review of known hazard 

information, it was determined that the 

SIDS data set would not further our 

understanding of the chemical’s 

properties. 

(2) The list of the chemical substances 

that the European Union (EU) exempted 

from its reporting requirements for 

existing chemical substances. 

(3) Certain other chemicals identified 

during the Executive Order 12866 

interagency review, for which EPA was 

able to quickly determine, based on a 

review of their chemical structures, 

properties, existing hazard information, 

and available exposure information, that 

IURA processing and use information is 

of low current interest. 

This list was then adjusted based 

upon the totality of information 

available to EPA during the Executive 

Order 12866 interagency review period 

to ensure that the chemicals included in 

this partial exemption were those for 

which EPA determined that IURA 

processing and use information is of low 

current interest. EPA chose these 

chemicals because almost all previously 

underwent a review to have gotten on 

these lists and, considering the time 

available during the Executive Order 

12866 interagency review, the Agency 

was able to utilize these lists, along with 

the Agency’s current knowledge and 

understanding of the individual 

chemical’s structure, properties, 

indications of hazards and potential 

exposures, to inform its determination 

that there is a low current interest in 

IURA processing and use information 

for these specific chemicals (Ref. 5). As 

indicated previously, EPA has 

established a process for revising the list 

of chemicals covered by this partial 

exemption, and intends to reconsider 

the chemicals identified in comments 

for applicability under this partial 

exemption. 

The list currently consists of the 

following chemicals: 

(1) Chemicals for which it had been 

determined that the SIDS data set would 

not further our understanding of the 

chemical’s properties, and not otherwise 

sponsored under the HPV Challenge 

Program: 50–70–4, 50–99–7, 56–87–1, 

57–50–1, 59–02–9, 69–65–8, 124–38–9, 

142–47–2, 1592–23–0, 7440–44–0, 

8001–21–6, 8001–22–7, 8001–26–1, 

8001–29–4, 8001–30–7, 8001–31–8, 

8001–78–3, 8001–79–4, 8002–03–7, 

8002–75–3, 8006–54–0, 8016–28–2, 

8016–70–4, 8021–99–6, 8029–43–4, 

9050–36–6, 16291–96–6, 61789–97–7, 

61789–99–9, 64147–40–6, 64755–01–7, 

65996–63–6, 65996–64–7, 68188–81–8, 

68334– 00–9, 68334–28–1, 68409–76–7, 

68425–17–2, 68439–86–1, 68476–78–8, 

68514–27–2, 68514–74–9, 68525–87–1, 

68918–42–3, 68952–94–3, 68989–98–0, 

and 73138–67–7. 

(2) Chemicals from the EU Existing 

Chemicals Program exempted list that 

are not currently otherwise a part of 

another Agency program such as the 

HPV Challenge Program: 50–81–7, 58–

95–7, 59–51–8, 87–79–6, 123–94–4, 

137–08–6, 150–30–1, 1317–65–3, 7440–

37–1, 7727–37–9, 7782–42–5, 8001–23–

8, 8002–13–9, 8002–43–5, 9004–53–9, 

9005–25–8, 11103–57–4, 26836–47–5, 

61789–44–4, 67701–01–3, 68002–85–7, 

68131–37–3, 68308–54–3, 68424–45–3, 

and 68424–61–3. 

(3) Chemicals otherwise identified by 

EPA based on consideration of the 

chemical’s structure, properties, existing 

hazard information, and available 

information concerning the extent of 

exposure, and which are not currently a 

part of another Agency program such as 

the HPV Challenge Program: 1333–74–0, 

7782–44–7, 68442–69–3, 68648–86–2, 

68648–87–3, 129813–58–7, 129813–59–

8 and 129813–60–1. 

You may use the process established 

in § 710.46(b)(2) to submit a request for 

the Agency to consider other chemical 

substances for inclusion under this 

partial exemption. Please ensure that 

you provide sufficient information in 

your requests to enable EPA to make the 

necessary determination after 

considering the totality of available 

information. If you have any questions 

about this process, please contact the 

technical person listed under FOR

FURTHER INFORMATION CONTACT for 

additional assistance. 

Under the list revision process, EPA 

will provide a written response to 

requests within 120 days of receipt, and 

will maintain copies of these responses 

in a public docket that will be 

established for each reporting cycle. In 

order to assist the Agency in completing 

any necessary revision to the list before 

the reporting period, any request for 

revising the list of chemicals under this 

partial exemption must be received by 

the Agency no later than January 1 of 

the year before the reporting period in 

question (i.e.,12 months prior to the 

reporting period). For example, any 

request for inclusion under this partial 

exemption must be submitted to EPA no 

later than January 1, 2004, i.e., 12 

months prior to the next reporting 

856 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

period, which begins on January 1, 

2005, for the 2006 submission period. If 

the request is submitted after this date, 

during an actual reporting period, or 

during the submission period, EPA is 

less likely to have sufficient time to 

complete its evaluation and make a 

determination, or issue the necessary 

rulemaking such that the decision can 

be effective for that submission period. 

Submitters should check the Federal 

Register for list revisions or may check 

the electronic CFR to identify what 

chemicals are on the partial exemption 

list prior to each reporting period. 

EPA intends to develop a standard 

operating procedure (SOP) for this 

specific chemical partial exemption 

process, which will outline the process 

steps, as well as provide guidance to 

EPA personnel on making such 

determinations. EPA would like to seek 

your input during the development of 

this SOP, as well as feedback on the 

implementation of this process, as part 

of IURA implementation workshops that 

are planned. 

One of the purposes of the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., can be achieved through federal 

agencies working together with the 

affected industries to design surveys 

that will achieve multiple purposes 

with a single survey instrument. EPA 

plans to identify and initiate dialogue 

that has the potential for generating 

additional paperwork burden reductions 

for the IURA. For example, the current 

USGS annual survey covers 

approximately 80 minerals, and 

accounts for at least 75% of the 

industrial production and 75% of the 

facilities included in the USGS survey. 

If you have identified other federal 

agency information collections that 

could satisfy the IURA purposes, or for 

which IURA information might serve as 

a viable substitute and have the 

potential to generate federal paperwork 

burden reductions, please contact the 

person listed under FOR FURTHER

INFORMATION CONTACT. 

Under the PRA, an agency may not 

conduct or sponsor, and a person is not 

required to respond to a collection of 

information, unless the agency has 

obtained approval for the activity from 

the Office of Management and Budget 

(OMB), an approval which must be 

renewed every 3 years. As part of the 

PRA approval renewal process, which 

includes an opportunity for public 

review and comment prior to OMB 

review, EPA intends to continue to 

evaluate this exemption process and 

will provide information about the 

chemicals evaluated, requests received, 

decisions made and related process 

elements and experiences as part of the 

information collection request (ICR) 

submitted to OMB. The Agency will 

also analyze the information collected 

from one reporting year to the next, in 

order to ensure that IURA information 

collection activities continue to meet 

the requirements of the PRA, including 

the demonstration of practical utility. 

e. Polymers. As a result of recent 

inquiries regarding the exemption of 

polymers from IUR reporting, EPA is 

clarifying this existing exemption. The 

exemption does not apply to a 

polymeric substance that has been 

hydrolyzed, depolymerized, or 

otherwise chemically modified, except 

in cases where the intended product of 

this reaction is totally polymeric in 

structure. The Agency’s intent under the 

exemption at 40 CFR 710.26(b) has 

always been (and continues to be under 

40 CFR 710.46(a)(1)) that the products of 

such reactions carried out on polymeric 

materials are excluded from IUR 

reporting only if they are intended to 

have a totally polymeric composition. 

There is no change in the IUR status of 

polymeric materials that have not 

undergone such reactions and are 

flagged in the TSCA Inventory. 

f. Microorganisms. EPA is clarifying 

this existing definition to ensure that 

the definition used for IURA purposes is 

consistent with the microorganisms rule 

at 40 CFR part 725 and to clarify the 

status of chemicals produced from 

living microorganisms. 

2. How have the reporting thresholds 

changed? EPA is raising the basic IUR 

reporting threshold from a production 

volume of 10,000 lbs. per year per site 

to 25,000 lbs. per year per site. Every 

person manufacturing a non–excluded 

chemical substance at or above the 

threshold will be required to report the 

information in Parts I and II of the 

revised Form U (see the regulatory text 

at §§ 710.52(c)(1), (c)(2), and (c)(3) and 

710.58). The increased IUR reporting 

threshold makes the IUR and Toxics 

Release Inventory (TRI) reporting 

thresholds equivalent for manufacturers. 

These thresholds also approximate the 

current TSCA section 5 premanufacture 

notification (PMN) low volume 

exemption threshold of 10,000 kg 

(approximately 22,000 lbs.). EPA is 

raising the basic IUR reporting threshold 

in order to reduce the number of reports 

filed, thus reducing the overall industry 

burden associated with this regulation. 

The new reporting threshold does not 

represent a finding of low exposure or 

low risk. 

EPA is also instituting a second, 

higher production volume threshold of 

300,000 lbs. per year per site. Persons 

who manufacture a reportable chemical 

substance at or above this level will be 

required to report the information in 

Part III of the revised Form U (see 

§ 710.52(c)(4) of the regulatory text) in 

addition to the information in Parts I 

and II of the revised Form U. The 

information reported on Part III of the 

form relates to the processing and use of 

chemical substances. EPA is instituting 

this separate threshold to limit 

processing and use data reporting to a 

subset of a few thousand IUR reportable 

chemicals out of the approximately 

76,000 chemicals listed on the TSCA 

Inventory. 

Information concerning lower 

production volume chemical substances 

is valuable, especially for identifying 

trends and additional substitute 

chemicals. However, wherever possible, 

the Agency has attempted to limit the 

reporting burden. In the future, EPA 

may find it necessary to collect 

information on chemicals at reporting 

thresholds below the thresholds 

introduced in this action. Although both 

the 25,000 lbs. and 300,000 lbs. 

thresholds are significantly higher than 

the current IUR 10,000 lbs. threshold, 

the enhanced information that will be 

gathered under the amended rule will 

enable the Agency and others to more 

efficiently identify those chemical 

substances warranting further, more in–

depth review, as well as chemicals of 

lesser concern (see Ref. 6). 

3. Have the reporting year, the 

submission period, or the reporting 

frequency changed? In order to provide 

clarification, two new definitions are 

being added at 40 CFR 710.43: 

‘‘reporting year’’ means the calendar 

year in which information to be 

reported to EPA during a submission 

period is generated and ‘‘submission 

period’’ means the period in which the 

information generated during the 

reporting year is submitted to EPA. 

‘‘Submission period’’ replaces the term 

‘‘reporting period,’’ as used under the 

current IUR regulations at 40 CFR part 

710. 

As proposed, EPA is changing the IUR 

reporting year to a calendar year basis 

from a corporate fiscal year basis. This 

change standardizes reporting time 

frames across IUR submitters and across 

various other reporting programs, such 

as the TRI program. 

Under the current IUR regulations at 

40 CFR 710.33(b), submitters are 

required to report on a recurring basis 

during a 120–day period from August to 

December (the ‘‘submission period’’

under IURA) every 4 years. In a separate 

action following this final rule, EPA 

intends to change the submission period 

to occur earlier in the year, for example 

from January 1 through May 1. This 

potential change is related in part to the 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 857

reporting year change in this final rule 

from fiscal year to calendar year. The 

August to December submission period 

was originally used because many 

companies’ fiscal years end in July, and 

starting the IUR submission period in 

late August allowed these companies to 

report their most current information. 

Companies will now report on a 

calendar year basis, making an earlier 

submission period more appropriate. 

Changing the submission period to 

occur earlier in the year would allow 

sites to submit their information closer 

to the period during which it was 

generated, as well as allow the Agency 

to obtain the information early in the 

year, thereby increasing the timeliness 

of the availability of the data. 

In this final rule, EPA has not 

changed the reporting frequency (every 

4 years), although EPA did consider 

alternative reporting frequencies (see 

the ‘‘Revised Economic Analysis for the 

Amended Inventory Update Rule,’’ Ref. 

7). This means that the first reporting 

year for IURA information will be 4 

years after the reporting year under the 

existing IUR, i.e., existing IUR reporting 

year is 2001, so the first reporting year 

under IURA will be 2005. The 

submission period will continue to 

occur in the year following the reporting 

year, i.e., existing IUR submission 

period is in 2002, so the first submission 

period for IURA will be in 2006. 

The final rule indicates that 

subsequent reporting years and 

submission periods will occur every 4 

years. In a separate action following this 

final rule, however, EPA intends to 

change the reporting frequency after the 

first reporting year under IURA (i.e., 

2005, with submission to EPA in 2006) 

from every 4 years to every 5 years. This 

would mean that, instead of occurring 

in 2009, the second reporting year under 

IURA would be 2010 (i.e., 5 years after 

2005), and would then occur every 5 

years thereafter. The submission period 

would continue to occur in the year 

following the reporting year, so it too 

would occur every 5 years (i.e., 2011, 

2016, etc.). In making this change, EPA 

also intends to change the 

recordkeeping period from 5 years to 6 

years. EPA agreed to make these 

changes within the next 12 months as 

part of the interagency review under 

Executive Order 12866 in an effort to 

further reduce the potential reporting 

burden related to IURA. EPA estimates 

that a 5–year frequency would save 

regulated entities about $50 million over 

20 years at a 3% discount rate (about a 

16% reduction), and $37 million over 

20 years at a 7% discount rate, and 

would still meet EPA’s most critical 

data needs (Ref. 8). 

For the first reporting year under 

IURA, EPA intends to issue guidance 

and conduct workshops to help the 

regulated community become 

familiarized with the revised 

regulations. A draft copy of the 

guidance for the 2006 submission 

period can be found in the docket for 

this rulemaking (Ref. 9). 

4. How have the recordkeeping 

requirements changed? EPA is requiring 

that persons subject to reporting under 

IURA retain records that document any 

information reported to EPA under 

IURA for a period of 5 years beginning 

with the effective date of that 

submission period (see § 710.57 of the 

regulatory text). The effective date of the 

submission period is the last day of the 

submission period (currently December 

23, although EPA intends to change this 

date, see Unit II.F.3.) in a year in which 

data must be submitted to EPA under 

IURA. Previously, submitters were 

required to retain records for 4 years 

(see 40 CFR 710.37). Under IURA, if a 

person submits a report in the year 

2006, that person will retain the records 

on which the report is based until 

December 23, 2011. This change ensures 

that the submitter will have the 

previous submission available when 

determining future reporting. The 

change will also aid in EPA’s 

enforcement of IUR by requiring that 

submitters maintain records that span 

successive submission periods. As 

described in Unit II.F.3., in a separate 

action EPA intends to change the 

reporting frequency from every 4 years 

to every 5 years. In that action, EPA also 

intends to change the recordkeeping 

period from 5 years to 6 years in order 

to continue to span successive 

submission periods. A 6–year 

recordkeeping period would require, 

under IURA, that if a person submits a 

report in the year 2006, that person will 

retain the records on which the report 

is based until December 23, 2012. 

Persons who are not required to report 

under the existing IUR because they 

manufacture less than the 10,000 lb. 

reporting threshold have been required 

to retain volume records as evidence to 

support decisions not to submit a report. 

In this rulemaking, EPA is eliminating 

this provision because EPA believes that 

this type of information is routinely 

retained by companies in the normal 

course of business. 

5. How have the data elements 

reported by all submitters changed? The 

new and revised data elements to be 

reported under the amended rule are 

discussed in this section. Data elements 

that are currently reported under IUR 

but that are not revised by these 

amendments are not generally discussed 

in this document. 

a. Technical contact identification 

(§ 710.52(c)(2)(i) of the regulatory text). 

In addition to the name of a person who 

will serve as technical contact for the 

submitter company, the parent company 

name, the contact person’s full mailing 

address, and the contact person’s 

telephone number, submitters must 

report the contact person’s e–mail 

address and the parent company Dun 

and Bradstreet Number. The technical 

contact person must be able to answer 

questions about the information on the 

revised Form U that is submitted by the 

company to EPA. 

b. Plant site identification 

(§ 710.52(c)(2)(ii) of the regulatory text). 

Submitters must report the plant site 

county or parish in addition to the 

information currently required for each 

plant site that is subject to reporting. 

EPA had additionally proposed to 

require submitters to report a plant site 

identification number in order to clearly 

identify the reporting site in a way that 

would allow the cross–linking of IUR 

information with information reported 

about the same plant site contained in 

other data bases. EPA specifically 

proposed requiring the reporting of a 

newly assigned Facility Registration 

Identifier (FRI), or, if the Facility 

Registry System were not yet in place in 

time for the publication of this final 

rule, the submitter would report the 

site’s RCRA number, if one has been 

assigned to the site. In this final rule, 

EPA has decided not to require the 

submission of a site identification 

number in addition to the Dun and 

Bradstreet number that submitters must 

continue to report. The Agency may 

instead make number assignments 

either directly on the reporting form 

after it is submitted to EPA, or prior to 

mailing out the form at the beginning of 

a submission period. Submitters will 

not be responsible for obtaining or 

reporting this number. 

c. Chemical identification 

(§ 710.52(c)(3)(i) of the regulatory text). 

Submitters must indicate which type of 

chemical identifying number they are 

reporting, in addition to the number 

itself. EPA no longer allows the use of 

certain of the previously used substitute 

identifying numbers (such as EPA–

assigned numbers for Test Market 

Exemption Applications, original TSCA 

Inventory form numbers, and numbers 

associated with Notices of Bona Fide

Intent to Manufacture) because they are 

difficult to cross–reference to CAS 

Registry numbers. Submitters must 

report a CAS Registry number, or, if a 

CAS Registry Number is not known to 

the submitter, the submitter must report 

858 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

either an EPA–designated accession 

number for confidential substances or a 

PMN case number. 

d. Confidentiality of production 

volume range (§ 710.52(c)(3)(v) of the 

regulatory text). Submitters must 

continue to report the specific 

production volume of the reportable 

chemical and may claim CBI protection 

for that production volume. 

Additionally, submitters may claim as 

CBI a pre–determined production 

volume range corresponding to the 

reported production volume number. 

This claim, if needed, would be separate 

from a CBI claim for the specific 

production volume. 

Submitters of specific CBI production 

volume data may allow the release of 

more general range information. EPA 

expects that roughly 50% of submitters 

of specific CBI production volume data 

will allow the public release of volume 

ranges. This expectation of reduced CBI 

claims is based on the CBI claim 

statistics associated with the 

development of the original TSCA 

Inventory (See ‘‘Inventory Update Rule 

(IUR) Technical Support Document: 

Evaluation of Likelihood of Confidential 

Business Information Claims for 

Production Volume Information’’ (Ref. 

10)) as well as comments received from 

industry concerning potential TSCA CBI 

reforms (Ref. 11). The range option will 

allow the public greater access to data 

on chemical production volumes, and 

the Agency will be better equipped to 

publicly release more aggregate 

production volume data relevant to its 

risk screening and other decisions. 

The production volume ranges in the 

final rule are 25,000 to 300,000 lbs.; 

300,000 to 1,000,000 lbs.; 1,000,000 to 

10,000,000 lbs.; 10,000,000 to 

50,000,000 lbs.; 50,000,000 to 

100,000,000 lbs.; 100,000,000 to 

500,000,000 lbs.; 500,000,000 to 

1,000,000,000 lbs.; and greater than 

1,000,000,000 lbs. per year. These 

ranges are similar to those first used in 

the development of the original TSCA 

Inventory, except for one change, i.e., 

the lowest range starts at the IURA 

reporting threshold of 25,000 lbs. rather 

than the 10,000 lb. threshold that was 

used in the current IUR. EPA 

additionally made one change to the 

ranges included in the proposed rule, 

i.e, the upper end of the first range and 

the lower end of the second range were 

raised to 300,000 lbs. from the 100,000 

lbs. range limit included in the 

proposal, resulting in ranges of 25,000 –

300,000 lbs. and 300,000 – 1,000,000 

lbs. This change makes the ranges 

consistent with the second reporting 

threshold of 300,000 lbs. or more (see 

§ 710.52(c)(4) of the regulatory text), and 

provides additional protection for 

submitters’ production volume range 

CBI claims. 

Under the proposed rule’s 100,000 

lbs. range limit for the lowest 

production volume range, submitters 

who did not claim the production 

volume range as CBI might have 

inadvertently provided the public with 

more information than they intended. 

For instance, for a submitter whose 

production volume was in the 100,000 

to 1,000,000 lbs. range, who did not 

claim their production volume range 

CBI, and who did not report any 

information in Part III of reporting Form 

U (the industrial processing and use and 

the commercial and consumer use 

information), public users of the data 

would be able to infer that the 

submitter’s production was somewhere 

between 100,000 to 300,000 lbs. per year 

– information which the submitter 

might have considered CBI. To protect 

against such inadvertent disclosures of 

CBI, EPA changed the production 

volume ranges to reflect the second 

reporting threshold of 300,000 lbs. EPA 

does not believe that the change 

significantly affects the utility of the 

data to the public. 

e. Number of potentially exposed 

workers (§ 710.52(c)(3)(vi) of the 

regulatory text). Submitters must report 

the range code that corresponds to their 

estimate of the total number of workers 

reasonably likely to be exposed to each 

reportable chemical substance at each 

plant site. EPA defines ‘‘reasonably 

likely to be exposed’’ as an exposure to 

a chemical substance which, under 

foreseeable conditions of manufacture, 

processing, distribution in commerce, or 

use of the chemical substance, is more 

likely to occur than to not occur. Such 

exposures would normally include, but 

not be limited to, exposure during 

activities such as charging reactor 

vessels; drumming; bulk loading; 

cleaning equipment; maintenance 

operations; materials handling and 

transfers; and analytical operations. 

Covered exposures include exposures 

through any route of entry (inhalation, 

ingestion, skin contact or absorption, 

etc.), but exclude accidental or 

theoretical exposures. 

Workers involved in chemical 

manufacturing, processing, and use are 

a subpopulation of concern to EPA, the 

Occupational Safety and Health 

Administration (OSHA) (Ref. 12), the 

National Institute of Occupational 

Safety and Health (NIOSH) (Ref. 13), 

and other organizations (e.g., labor 

unions). Workers may often be exposed 

to chemical substances in higher doses 

and with greater frequency than the 

general population, and may therefore 

be at potentially greater risk of adverse 

health effects. The number of workers 

reasonably likely to be exposed to 

specific chemical substances is 

important to EPA and other 

organizations in developing screening 

level exposure scenarios. These 

scenarios are then used to develop 

priorities for testing, more detailed risk 

assessment, and risk management. 

Under IURA, submitters are required 

to use ranges rather than specific values 

for reporting certain data, including the 

number of workers reasonably likely to 

be exposed and the number of 

processing or use sites. The ranges for 

reporting the estimated number of 

potentially exposed workers are found 

in § 710.52(c)(3)(vi) of the regulatory 

text. In general, reporting these ranges 

reduces the potential burden to 

submitters of developing a precise point 

estimate for the data element. The use 

of ranges should additionally result in 

fewer CBI claims than if precise point 

estimates were provided because ranges 

tend to reveal less sensitive information 

than specific estimates while still 

conveying sufficient information useful 

to effectively screen chemical risks. 

Submitters are permitted to claim the 

reported ranges as confidential if 

revealing even this general information 

would disclose information of a 

sensitive nature. 

f. Maximum concentration 

(§ 710.52(c)(3)(vii) of the regulatory 

text). Submitters must report the 

maximum concentration, measured by 

weight, of the reportable chemical 

substance at the time it leaves the 

submitter’s manufacturing site or, if it is 

a site-limited chemical, at the time it is 

reacted on-site to produce a different 

chemical substance. This information is 

to be reported regardless of the various 

physical forms in which the chemical 

may be sent off-site or reacted on–site. 

Concentration ranges for use in 

reporting are found in § 710.52(c)(3)(vii) 

of the regulatory text. 

Concentration is an important 

variable to consider when estimating the 

magnitude of potential exposures. 

Information about the maximum 

concentration of a chemical substance 

present at processing and use sites is 

frequently used in chemical risk 

screening in the review of PMNs for 

new chemical substances required by 

section 5 of TSCA and is used to the 

extent it is available in screening 

chemicals on the TSCA Inventory. For 

example, EPA has developed standard 

methods to estimate dermal exposures 

that workers may experience while 

performing common industrial 

operations such as sampling and 

loading chemicals into drums. These 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 859

standard methods use maximum 

concentration information to estimate 

upper limits to exposure estimates. If 

EPA is aware that a chemical substance 

is processed or used only as a fraction 

of a mixture with other chemical 

substances, exposure estimates may be 

adjusted downward accordingly. For 

example, a chemical substance which is 

a component of a liquid mixture exerts 

a lower vapor pressure than it would as 

a pure chemical substance. Because 

higher vapor pressure is associated with 

increasing inhalation exposure to a 

chemical substance, the concentration 

of a chemical substance in a liquid 

mixture impacts the exposure 

assessment. 

A chemical may be produced in 

multiple physical forms and in multiple 

formulations and products. As 

described in Unit II.F.5.g., EPA is 

requiring reporting of each of the 

physical forms in which a chemical is 

sent off–site. For the purpose of 

exposure screening, EPA is requiring 

only the reporting of the maximum 

concentration, regardless of the various 

physical forms in which a chemical may 

be sent off-site. 

EPA had proposed that submitters 

also report the average concentration of 

the chemical when leaving the 

manufacturing site (at 64 FR 46788). 

EPA is not promulgating this 

requirement because of the potential 

difficulty of determining the average 

concentration. For example, a submitter 

could produce many formulations 

containing a particular chemical 

substance, making a determination of 

average concentration difficult. 

g. Physical form (§ 710.52(c)(3)(viii) of 

the regulatory text). Submitters must 

report the physical form(s) of the 

chemical at the time it leaves the site of 

manufacture or, if the chemical is sitelimited, at the time it is reacted on site 

to produce a different chemical 

substance. The list of physical forms 

from which submitters must select is 

found in § 710.52(c)(3)(viii) of the 

regulatory text. Further discussion on 

physical form reporting is found in Unit 

III.B.1.a. 

The physical form of a chemical is an 

important factor to consider when 

estimating magnitudes and 

concentrations of potential exposures. 

EPA’s analyses of TRI and PMN data 

demonstrated that the physical state of 

a chemical is a determining factor in 

predicting the potential for industrial 

releases of chemicals, and hence, 

exposures to humans and the 

environment. The results of the analyses 

are provided in a technical support 

document that was developed by EPA in 

support of this rule (‘‘Inventory Update 

Rule (IUR) Amendments Technical 

Support Document: Exposure-Related 

Data Useful for Chemical Risk 

Screening,’’ Ref. 14). The physical state, 

which provides information on 

volatility and how the chemical is likely 

to be handled during manufacturing, 

processing, and use, is an important 

data element for the purpose of 

exposure and risk screening. 

h. Percent production volume 

(§ 710.52(c)(3)(ix) of the regulatory text). 

Submitters are required to report the 

percentage of total production volume 

(as reported under regulatory text 

§ 710.52(c)(3)(iv)) of the reportable 

chemical substance that is associated 

with each physical form reported. 

Percent production volume estimates 

will allow the Agency to aggregate, on 

a case-by-case basis, the production 

volume of a particular physical form for 

a given chemical across multiple sites. 

These determinations will allow EPA to 

better characterize the risk associated 

with chemicals that are manufactured in 

physical forms that typically result in 

higher exposures, such as volatile 

liquids or powders, but that are 

produced in small quantities. These 

percent production volume estimates 

will help put the physical form 

information into context. Estimates 

must be rounded off to the nearest 10% 

of production volume. 

6. What new definitions have been 

added to explain or reworded to clarify 

the reporting requirements? EPA has 

reorganized the definition section of the 

regulatory text associated with the 

original Inventory and IUR. There are 

now three definition sections. The 

existing § 710.2 contains definitions 

relevant primarily to the compilation of 

the original Inventory, although a few of 

these definitions are also relevant to 

both IUR and IURA. EPA has recodified 

these general definitions in § 710.3. 

Definitions relevant only to IUR, which 

were originally in § 710.2, are now in 

§ 710.23. Section 710.43 contains 

definitions relevant only to IURA. This 

reorganization clarifies the relationships 

between the definitions and the various 

rules, and has no substantive effect. 

Two existing definitions are being 

clarified (§ 710.3 of the regulatory text). 

EPA defines ‘‘manufacture’’ to mean to 

manufacture, produce, or import for 

commercial purposes and ‘‘manufacture 

or import ‘for commercial purposes’’’ to 

mean to manufacture, produce, or 

import with the purpose of obtaining an 

immediate or eventual commercial 

advantage, and includes, for example, 

the manufacture or import of any 

amount of a chemical substance or 

mixture: (1) For commercial 

distribution, including for test 

marketing, or (2) for use by the 

manufacturer, including use for product 

research and development, or as an 

intermediate. 

Certain new definitions are being 

added to § 710.43 as a result of this final 

rule. 

a. Known to or reasonably 

ascertainable by. TSCA section 8(a)(2) 

authorizes EPA to require persons to 

report information that is known to or 

reasonably ascertainable by the 

submitter. For the purposes of reporting 

under IURA, a submitter will report 

information described in the regulatory 

text at § 710.52(c)(1), (c)(2), and (c)(3) 

that is known to or reasonably 

ascertainable by the submitter. This 

means all information in a person’s 

possession or control, plus all 

information that a reasonable person 

similarly situated might be expected to 

possess, control, or know. 

b. Readily obtainable information. 

TSCA section 8(a)(2) authorizes EPA to 

require persons to report information 

that is known to or reasonably 

ascertainable by the submitter. Under 

IURA, a submitter will report processing 

and use information (i.e., the 

information reported for sites at which 

the 300,000 lbs. threshold has been met 

or exceeded) only to the extent that such 

information is ‘‘readily obtainable’’ by 

the submitter’s management and 

supervisory employees responsible for 

manufacturing, processing, distributing, 

technical services, and marketing of the 

reportable chemical substance (see 

regulatory text § 710.43). Extensive file 

searches are not required. The ‘‘readily 

obtainable’’ standard for processing and 

use information requires less effort on 

the part of the submitter than the 

‘‘known to or reasonably ascertainable 

by’’ standard that applies to all other 

IUR reporting (see regulatory text 

§ 710.43), while providing sufficiently 

precise processing and use information 

for screening level reviews. In addition, 

the ‘‘readily obtainable’’ standard limits 

the reporting burden associated with 

processing and use reporting and is 

identical to the standard currently in 

effect under EPA’s TSCA Section 8(a) 

Preliminary Assessment Information 

Rule (PAIR) (See 40 CFR 712.7). The 

‘‘readily obtainable’’ definition is 

further discussed in Unit III.D.2. 

c. Reasonably likely to be exposed. 

For the purposes of reporting under 

IURA, reasonably likely to be exposed 

means an exposure to a chemical 

substance which, under foreseeable 

conditions of manufacture (including 

import), processing, distribution in 

commerce, or use of the chemical 

substance, is more likely to occur than 

not to occur. Such exposures would 

860 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

normally include, but would not be 

limited to, activities such as charging 

reactor vessels, drumming, bulk loading, 

cleaning equipment, maintenance 

operations, materials handling and 

transfers, and analytical operations. 

Covered exposures include exposures 

through any route of entry (inhalation, 

ingestion, skin contact, etc.), but 

excludes accidental or theoretical 

exposures. 

d. Use. For the purpose of reporting 

under IURA, EPA is defining ‘‘use’’ as 

any utilization of a chemical substance 

or mixture that is not otherwise covered 

by the terms ‘‘manufacture’’ or 

‘‘process’’ (see regulatory text § 710.43). 

For example, the activity of processing 

a solvent into a paint formulation is 

considered ‘‘processing’’ rather than 

‘‘use’’ because the activity incorporates 

the chemical substance (the solvent) 

into a formulation. If the paint 

formulation containing the solvent is 

then applied to a metal or wood surface 

(e.g., cars), this application would be 

considered a use activity. Relabeling or 

redistributing a container holding a 

chemical substance or mixture where no 

repackaging occurs does not constitute 

use or processing of the chemical 

substance or mixture. 

e. Repackaging. For the purpose of 

reporting under IURA, ‘‘repackaging’’ is 

defined as the physical transfer of a 

chemical substance or mixture (as is) 

from one container to another container 

or containers in preparation for 

distributing the chemical substance or 

mixture in commerce. This definition 

does not apply to sites that only relabel 

or redistribute the reportable chemical 

substance without removing the 

chemical substance from the container 

in which it is received or purchased. 

f. Industrial use. EPA defines 

‘‘industrial use’’ for purposes of 

reporting under IURA as use at a site at 

which one or more chemical substances 

or mixtures are manufactured or 

processed (see § 710.43 of the regulatory 

text). 

g. Commercial and consumer use. For 

purposes of reporting under IURA, EPA 

defines ‘‘commercial use’’ as the use of 

a chemical substance or mixture in a 

commercial enterprise providing 

saleable goods or a service, such as 

painting contractors using paint 

products. A ‘‘consumer use,’’ on the 

other hand, means the use of a chemical 

substance that is directly, or as part of 

a mixture, sold to or made available to 

consumers for their use in or around a 

permanent or temporary household or 

residence, a school, or recreational areas 

(see § 710.43 of the regulatory text). 

Exposures to commercial and consumer 

products are similar for risk screening 

purposes because existing screening 

level assessment methods are not 

sophisticated enough to distinguish 

between these exposures. 

h. Intended for use by children. For 

purposes of reporting under IURA, EPA 

defines ‘‘intended for use by children’’

as the use of a chemical substance or 

mixture in or on a product that is 

specifically intended for use by children 

age 14 or younger. A chemical substance 

or mixture is intended for use by 

children when the submitter answers 

‘‘yes’’ to at least one of the following 

questions for the product into which the 

submitter’s chemical substance or 

mixture is incorporated: (1) Is the 

product commonly recognized (i.e., by a 

reasonable person) as being intended for 

children age 14 or younger; (2) Does the 

manufacturer of the product state 

through product labeling or other 

written materials that the product is 

intended for or will be used by children 

age 14 or younger; or (3) Is the 

advertising, promotion, or marketing of 

the product aimed at children age 14 or 

younger? 

i. Reportable chemical substance. For 

the purposes of reporting under IURA, 

a reportable chemical substance is a 

chemical substance described in 

§ 710.45 of the regulatory text. 

j. Reporting year. For the purposes of 

reporting under IURA, the reporting 

year is the calendar year in which 

information to be reported to EPA 

during a submission period is generated, 

i.e., calendar year 2005 and the calendar 

year at 4–year intervals thereafter. For 

instance, for information submitted in 

2006, the information will be generated 

during the period from January 1 to 

December 31, 2005. 

k. Submission period. For the 

purposes of reporting under IURA, the 

submission period is the period in 

which the information generated during 

the reporting year is submitted to EPA. 

For instance information generated 

during the period from January 1 to 

December 31, 2005 (i.e., when the 

chemical substance is manufactured) 

will be submitted during the 2006 

submission period. 

l. Site-limited. For purposes of 

reporting under IURA, EPA defines 

‘‘site-limited’’ to mean that a chemical 

substance is manufactured and 

processed only within a site and is not 

distributed for commercial purposes as 

a substance or as part of a mixture or 

article outside the site. Imported 

substances are never site-limited. 

Although a site-limited chemical 

substance is not distributed for 

commercial purposes outside the site at 

which it is manufactured and processed, 

the substance is considered to have been 

manufactured and processed for 

commercial purposes. 

7. What new data elements are 

reportable by only larger production 

volume manufacturers? As described in 

Unit II.F.2., EPA is replacing the current 

IUR reporting threshold of 10,000 lbs. 

per year per site with two new 

production volume reporting thresholds 

of 25,000 lbs. and 300,000 lbs. per year 

per site. Each person manufacturing a 

reportable substance at or above the 

25,000 lbs. per year per site threshold is 

required to complete at least a partial 

report containing the information in 

Parts I and II of the revised Form U. 

Persons who manufacture a reportable 

substance at or above the 300,000 lbs. 

per year per site threshold are required 

to complete a full report, providing the 

information in Part III of the revised 

Form U in addition to the information 

in Parts I and II. Part III concerns the 

processing and use of chemical 

substances. 

a. Processing and use information 

(§ 710.52(c)(4) of the regulatory text). 

Submitters with plant sites at which a 

reportable chemical substance is 

manufactured in annual quantities of 

300,000 lbs. or more must report 

processing and use information under 

IURA. EPA requires submitters to report 

the information described in 

§ 710.52(c)(4) of the regulatory text 

concerning the processing and use of 

each reportable chemical substance at 

sites that receive a reportable chemical 

substance from the submitter site either 

directly or indirectly (including through 

a broker/distributor, from a customer of 

the submitter, etc.), whether the 

recipient site(s) are controlled by the 

submitter site or not. Processing and use 

information must be reported only to 

the extent that the data, or an estimate, 

is ‘‘readily obtainable’’ by the submitter 

(see Unit II.F.6.b.). 

i. Industrial processing or use 

operations (§ 710.52(c)(4)(i)(A) of the 

regulatory text). Submitters must report 

the industrial processing or use 

operation(s) at each site that receives the 

reportable substance from the submitter 

site (whether the recipient site(s) are 

controlled by the submitter site or not). 

The categories for reporting are listed in 

§ 710.52(c)(4)(i)(A) of the regulatory 

text. 

ii. North American Industrial 

Classification System (NAICS) Code 

(§ 710.52(c)(4)(i)(B) of the regulatory 

text). Submitters must report the five–

digit NAICS code(s) that best describe(s) 

the industrial processing or use 

activities at the sites that receive a 

reportable chemical substance from the 

submitter either directly or indirectly 

(including through a broker/distributor, 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 861

from a customer of the submitter, etc.), 

whether the recipient site(s) are 

controlled by the submitter site or not. 

The NAICS codes, published by the 

Office of Management and Budget 

(OMB), have superseded the prior 

system of Standard Industrial 

Classification (SIC) codes (Ref. 15). 

Submitters must report these codes to 

the extent the information is readily 

obtainable for processing or use 

activities at sites that process or use a 

reportable chemical substance received 

from the submitter. EPA does not intend 

for manufacturers to survey their 

customers or distributors to precisely 

identify the appropriate NAICS codes at 

their downstream sites. 

The NAICS classification system is 

being used in IURA to describe the 

industrial setting in which chemical 

exposures associated with the industrial 

processing or use of a chemical 

substance may occur. Exposure to a 

chemical substance typically varies 

among industries. The NAICS code in 

conjunction with the Industrial 

Function Category (IFC) code and the 

processing or use operation will define 

the industrial, commercial, or consumer 

setting so that the appropriate scenarios 

can be applied to estimate worker, 

community, and environmental 

exposures to the chemical substance. 

The NAICS codes which best describe 

the industrial activities associated with 

each reported industrial processing or 

use operation must be provided. If more 

than 10 NAICS codes apply to a 

reportable chemical substance, 

submitters need only report the 10 

NAICS code, IFC and processing or use 

operation combinations that 

cumulatively represent the largest 

percentage of the substance’s 

production volume, measured by 

weight. Submitters may also report the 

same NAICS code multiple times if the 

chemical being reported has several 

industrial functions or multiple 

processing or use operations. This 

limitation on reporting is intended to 

minimize submitters’ reporting burden. 

iii. Industrial function category (IFC) 

(§ 710.52(c)(4)(i)(C) of the regulatory 

text). Submitters must report the IFCs 

that best represent the specific manner 

in which a chemical substance is used 

within each NAICS code reported. 

Submitters may report the same 

function category under different NAICS 

codes. The IFCs to be used are listed in 

the regulatory text at § 710.52(c)(4)(i)(C). 

A NAICS code and IFC combination 

sufficiently defines a potential exposure 

scenario for risk screening and priority–

setting purposes. EPA conducted 

studies to determine whether 

information regarding the industrial 

sectors in which a chemical substance is 

processed and used, and information 

regarding the function a chemical 

substance performs within industrial 

processes, are useful for the purpose of 

screening level exposure assessments. 

These studies demonstrated that this 

type of information provides indications 

of the route, magnitude, and 

concentration of potential chemical 

exposures to humans and to the 

environment. The results of the studies 

are provided in two of the technical 

support documents that EPA developed 

in support of this rule (Refs. 14 and 16). 

IFCs are also useful in estimating the 

frequency and duration of chemical 

substance exposures by indicating the 

type of application in which a chemical 

will be used (e.g., solvents (for cleaning 

and degreasing) or intermediate). The 

relationship between industrial function 

categories and the frequency and 

duration of exposure to chemical 

substances is particularly useful in 

developing exposure assessments in 

EPA’s New Chemicals Program. These 

data elements are important elements in 

developing useful exposure scenarios. 

In the absence of these data, EPA often 

uses conservative estimates that may 

indicate a greater risk than is actually 

the case. Data that will be obtained 

under IURA will enable EPA to make 

more realistic characterizations of 

exposure, instead of ‘‘worst case’’

assumptions. 

iv. Percentage of production volume 

attributable to each combination of 

NAICS code and industrial function 

category in each processing or use 

operation (§ 710.52(c)(4)(i)(D) of the 

regulatory text). Submitters must 

estimate the percentage of total 

production volume attributable to each 

reported combination of NAICS code 

and IFC in each processing or use 

operation, to the extent that such 

information is readily obtainable. 

Estimates must be rounded off to the 

nearest 10% of production volume. 

Submitters are not permitted to round 

off to zero percent if the production 

volume attributable to a NAICS code/

IFC/processing or use operation 

combination is 300,000 lbs. or more and 

accounts for 5% or less of the total 

production volume of a reportable 

chemical substance. In such cases, 

submitters must report the percentage of 

production volume attributable to that 

combination to the nearest 1% of 

production volume. This exception to 

the general rounding rule will ensure 

that adequate use information is 

reported for the larger production 

volume chemical substances. 

The total percent production volumes 

associated with the NAICS code/IFC 

combinations may add up to more than 

100%, given that the submitter is 

reporting on distribution of a chemical 

to sites in its control as well as 

downstream sites, some of which are 

not immediate purchasers from the 

original manufacturing site. 

Additionally, the total percent 

production volume may add up to less 

than 100% if the submitter cannot 

readily obtain information about how all 

of its production volume is processed or 

used by industry. 

v. Number of processing or use sites 

(§ 710.52(c)(4)(i)(E) of the regulatory 

text). Submitters must report estimates 

of the total number of industrial sites, 

including those beyond the submitter’s 

control, that process or use each 

reportable chemical substance 

manufactured by the submitter, with 

respect to each combination of NAICS 

code and IFC in each processing or use 

operation. The ranges that will be used 

for reporting the number of sites can be 

found at § 710.52(c)(4)(i)(E) of the 

regulatory text. For risk screening 

purposes, the number of sites at which 

chemical substances are manufactured, 

processed, or used is a useful indicator 

of the number of ecosystems and the 

size of the general population 

potentially exposed to the chemical 

substances. 

vi. Number of workers 

(§ 710.52(c)(4)(i)(F) of the regulatory 

text). Submitters must report estimates 

of the total number of workers, 

including those at sites not under the 

submitter’s control, that are reasonably 

likely to be exposed while processing or 

using the reportable chemical substance, 

with respect to each combination of 

NAICS code and IFC in each processing 

or use operation. The approximate 

number of workers will be reported 

using the same definitions and ranges 

described under Unit II.F.5.e. The 

difference in reporting worker exposure 

information under this section is that 

such information need be reported only 

to the extent that it is readily obtainable. 

b. Commercial and consumer use 

information (§ 710.52(c)(4)(ii) of the 

regulatory text). Submitters must report 

information concerning the commercial 

and consumer uses of each reportable 

chemical substance, whether the site(s) 

at which the chemical substance is used 

are controlled by the submitter site or 

not. As for the industrial processing and 

use information described in Unit 

II.F.7.a., commercial and consumer use 

information must be reported only by 

sites at which a chemical substance is 

manufactured in annual quantities of 

300,000 lbs. or more, and submitters are 

only required to report the information 

to the extent that it is readily obtainable. 

862 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

Consumers comprise a subpopulation 

of particular concern to EPA, the 

Consumer Products Safety Commission 

(CPSC), and other governmental and 

non–governmental organizations. 

Information from submitters about 

whether the chemical substances they 

manufacture are used in consumer 

products is useful in estimating the 

potential risks to consumers that result 

from chemical exposures. In the absence 

of more specific data, EPA often 

assumes for risk screening purposes that 

large, unprotected populations may 

potentially be exposed to the chemical 

substances in consumer products. EPA 

is also working with industry and other 

stakeholders to develop hazard, 

exposure, and risk assessments 

regarding chemicals to which children 

are exposed. The commercial and 

consumer product information that will 

be reported under IURA will be used by 

EPA in the identification of chemicals 

that might be included in these 

programs, and may contribute to 

exposure assessments for these 

chemicals. 

i. Commercial and consumer product 

categories (§ 710.52(c)(4)(ii)(A) of the 

regulatory text). Submitters must report 

up to 10 categories that best describe the 

commercial and consumer products in 

which the reportable chemical 

substance is used (whether the recipient 

site(s) are controlled by the submitter 

site or not). If more than 10 categories 

apply, submitters need only report the 

10 categories for the chemical substance 

that cumulatively represent the largest 

percentage of the submitter’s production 

volume, measured by weight. The 

commercial and consumer product 

(CCP) categories are listed at 

§ 710.52(c)(4)(ii)(A) of the regulatory 

text. Information on the use of 

chemicals in CCPs is useful in 

estimating the frequency and duration 

of chemical substance exposures. In the 

absence of other information, consumers 

are often assumed to experience less 

controlled, but less frequent exposures 

than workers. The data that will be 

obtained under IURA will enable EPA to 

make more realistic characterizations of 

exposure, instead of ‘‘worst case,’’

overly conservative assumptions. 

ii. Products intended for use by 

children (§ 710.52(c)(4)(ii)(B) of the 

regulatory text). Submitters must 

indicate, within each reported CCP 

category, whether, based on readily 

obtainable information, any amount of 

each reportable chemical substance 

manufactured by the submitter is or is 

not present in (for example, a plasticizer 

chemical used to make pacifiers) or on 

(for example, as a component in the 

paint on a toy) any products intended 

for use by children, regardless of the 

concentration of the substance, or 

indicate that such information is not 

readily obtainable. 

EPA defines ‘‘intended for use by 

children’’ in § 710.43 of the regulatory 

text and in Unit II.F.6.h. Using this 

definition, if a submitter determines, 

based on readily obtainable information, 

that its chemical substance or mixture is 

used in or on a product that is intended 

to be used by children age 14 or 

younger, the submitter would indicate 

this on Form U. For example, EPA 

believes that certain products, like 

crayons, coloring books, diapers, and 

toy cars – to name a few – are typically 

intended to be used by children age 14 

or younger. As such, if a submitter 

determines, based on readily obtainable 

information, that its chemical substance 

or mixture is used in crayons and toy 

cars, that submitter would report a ‘‘Y’’

in the Children’s Use column on Form 

U for categories C01 and C10. 

On the other hand, EPA believes that 

certain products, like household 

cleaning products, automotive products, 

and lubricants--to name a few--are 

typically not intended to be used by 

children age 14 or younger. As such, if 

a submitter determines, based on readily 

obtainable information, that its chemical 

substance or mixture is used in 

automotive care products and 

lubricants, that submitter could report a 

‘‘N’’ in the Children’s Use column on 

Form U for categories C03 and C09. 

For further illustration, some 

examples of products that are typically 

intended for use by children 14 or 

younger are provided for each 

commercial and consumer use category 

(this listing is not intended to be 

exhaustive and should therefore not be 

considered limiting):

Code Category Examples of Children’s Products 

C01 Artists’ supplies Crayons, children’s markers 

C02 Adhesives and sealants Craft glue, model glue 

C03 Automotive care products Typically products in this category are not likely to be 

intended for use by children 14 or younger 

C04 Electrical and electronic products Electronic games, remote control cars, toys 

C05 Glass and ceramic products Porcelain dolls 

C06 Fabrics, textiles and apparel Pajamas 

C07 Lawn and garden products (non-pesticidal) Lawn and gardening tools designed specifically for 

children, e.g., children’s rake 

C08 Leather products Shoes, jackets, baseball gloves 

C09 Lubricants, greases and fuel additives Typically products in this category are not likely to be 

intended for use by children 14 or younger 

C10 Metal products Toy trucks, toy cars, wagon 

C11 Paper products Diapers, baby wipes, coloring books 

C12 Paints and coatings Finger paints, water color kits intended for children’s 

use 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 863

Code Category Examples of Children’s Products 

C13 Photographic chemicals Typically products in this category are not likely to be 

intended for use by children 14 or younger 

C14 Polishes and sanitation goods Typically products in this category are not likely to be 

intended for use by children 14 or younger 

C15 Rubber and plastic products Pacifiers, action figures, balls 

C16 Soaps and detergents Baby shampoo, children’s bubble bath 

C17 Transportation products Child’s car seat 

C18 Wood and wood furniture Baby cribs, changing tables, wooden toys 

C19 Other Other items specifically intended for use by children 

age 14 or younger 

EPA chose the phrase ‘‘intended for 

use by children’’ because it appears in 

the Federal Hazardous Substances Act 

(FHSA) (15 U.S.C. 1261 et seq.) and has 

been applied by the Consumer Product 

Safety Commission (CPSC) for over 20 

years. While not specifically defined in 

FHSA or its implementing regulations, 

the CPSC regulations list several factors 

that CPSC considers in determining 

whether a product is a ‘‘children’s 

product’’ intended for use by children 

(16 CFR 1501.2(b)). After consultation 

with CPSC, EPA adapted these factors 

for the purpose of defining ‘‘intended 

for use by children’’ for IURA purposes. 

EPA based the ages for the definition, 

i.e., 14 or younger, on the Standard 

Consumer Safety Specification on Toy 

Safety issued by the American Society 

for Testing and Materials (ASTM), 

Standard: ASTM F963–96a. This 

standard covers age groups through 14 

years and defines ‘‘toy’’ as: ‘‘any object 

designed, manufactured, or marketed as 

a plaything for children through the age 

of 14 years’’ (Ref. 17, section 3.1.33). 

Obtaining information indicating that 

a chemical substance or mixture is used 

in a product that is intended for use by 

children will enable the Agency and 

others to identify chemicals affecting 

this particularly sensitive population. 

EPA has long had an interest in 

protecting children from unreasonable 

adverse affects associated with exposure 

to chemicals. In 1995, EPA established 

a policy to ensure that environmental 

health risks of children are explicitly 

and consistently evaluated in our risk 

assessments, risk characterizations, and 

environmental and public health 

standards (see http://yosemite.epa.gov/

ochp/ochpweb.nsf/homepage). 

Environmental health threats to 

children are often difficult to recognize 

and assess because of limited 

information to identify where children’s 

exposures occur and limited 

understanding of when and why 

children’s exposures and responses are 

different from those of adults. 

In 1997, Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997), 

specifically directed each Federal 

agency to make it a high priority to 

identify, assess, and address children’s 

environmental health and safety risks. It 

also created a Task Force on 

Environmental Health Risks and Safety 

Risks to Children. On October 9, 2001, 

President Bush signed Executive Order 

13229, entitled Amendment to 

Executive Order 13045, Extending the 

Task Force on Environmental Health 

Risks and Safety Risks to Children (66 

FR 52013, October 11, 2001), extending 

the work of the Task Force by another 

18 months. These Executive Orders 

illustrate the interest in and the 

importance placed on addressing 

children’s environmental health and 

safety risks. 

The inclusion of the children’s use 

category in IURA will provide the 

Agency and others with valuable 

information about the relationship 

between the IUR chemicals and 

products intended for use by children 

14 or younger. This information will 

allow the Agency to respond to 

concerns about chemicals used in the 

manufacture of products intended for 

use by children, enabling the Agency to 

identify those chemicals that are 

reported as not being used in children’s 

products, those chemicals that are used 

in children’s products, and those 

chemicals where it is not known if they 

are used in children’s products. This 

initial screen will then allow EPA and 

others to identify those chemicals used 

in children’s products that might 

warrant further investigation or 

assessment, and thereby allow EPA, as 

well as other interested parties and 

affected entities, to better prioritize such 

assessments and maximize available 

resources. 

iii. Percentage of production volume 

attributable to each commercial and 

consumer product category 

(§ 710.52(c)(4)(ii)(C) of the regulatory 

text). Submitters must estimate the 

percentage of their site production 

volume for each reportable chemical 

substance that is attributable to each 

specific commercial and consumer end–

use. This information must be submitted 

to the extent that it is readily obtainable. 

Estimates must be rounded off to the 

nearest 10% of production volume. 

However, a CCP category which 

accounts for 5% or less of the total 

production volume of a reportable 

chemical substance cannot be rounded 

off to zero percent if the production 

volume attributable to that CCP category 

is greater than or equal to 300,000 lbs. 

In such cases, submitters must report 

the percentage of production volume 

attributable to that CCP category to the 

nearest 1% of production volume. This 

exception to the general rounding rule 

will ensure that adequate use 

information is reported for the larger 

production volume chemical 

substances. 

The total percent production volumes 

reported may add up to more than 

100%, given that the submitter is 

reporting on distribution of a chemical 

to sites in its control as well as 

downstream sites, some of which are 

not immediate purchasers from the 

original manufacturing site. 

Additionally, the total percent 

production volume may add up to less 

than 100% if the submitter cannot 

readily obtain information about how all 

of its production volume is used in 

commercial and consumer products. 

864 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

iv. Maximum concentration in 

commercial and consumer products 

(§ 710.52(c)(4)(ii)(D) of the regulatory 

text). Submitters must report the 

maximum concentration (measured by 

weight) of each reportable chemical 

substance in each commercial and 

consumer product category. In 

complying with this requirement, 

submitters will select from the list of 

concentration ranges provided in 

§ 710.52(c)(3)(vii) in the regulatory text. 

Concentration is further discussed in 

Unit III.B.1.b. As with the other 

processing and use information that 

submitters must report, such 

information will be reported only to the 

extent that it is readily obtainable by the 

submitter. 

8. What changes have been made to 

requirements for making CBI claims? 

Submitters are able to claim information 

submitted to EPA under this amended 

rule as confidential if they have reason 

to believe that release of the information 

would reveal trade secrets or 

confidential commercial or financial 

information, as provided by section 14 

of TSCA and 40 CFR part 2. Claims of 

confidentiality must be asserted at the 

time information is submitted to EPA. 

EPA’s procedures for processing and 

reviewing confidentiality claims are set 

forth at 40 CFR part 2, subpart B. EPA 

strongly encourages submitters to 

review confidentiality claims carefully 

to ensure that the information in 

question falls within the protection of 

TSCA section 14, and to limit invalid 

confidentiality claims as much as 

possible. 

Submitters will have an opportunity 

to make CBI claims for most of the 

information reported under IURA. To 

claim information as confidential, a 

submitter must check the appropriate 

box and sign the certification statement 

on the reporting form. If a submitter 

fails to do so, EPA could release the 

information to the public without 

further notice to the submitter. As in the 

past TSCA Inventory Update collections 

and the initial TSCA Inventory 

collection, by signing the certification 

statement the submitter certifies that its 

claims of confidentiality are true and 

correct. Procedures for claiming 

information submitted electronically 

(such as a submission on diskette) as 

CBI will be specified in the instruction 

manual that will be available each 

submission period as described in 

§ 710.59 of the regulatory text. CBI 

should not be submitted by e–mail. A 

discussion about CBI claims under 

IURA is provided in this unit. 

a. Upfront substantiation for plant site 

identity. Submitters are required to 

provide upfront substantiation for CBI 

claims for plant site identity, in a 

manner similar to the upfront 

substantiation of chemical identity 

under the existing IUR (see 40 CFR 

710.38). Under IURA (see § 710.58(d) of 

the regulatory text), a submitter may 

assert a claim of confidentiality for a 

plant site identity if the submitter 

believes that releasing that identity 

would reveal trade secrets or 

confidential commercial or financial 

information, as provided by TSCA 

section 14. Submitters in past IUR 

information collections have claimed in 

excess of 15% of plant site identities as 

CBI. While the Agency does not 

question the occasional need for this 

claim, it believes that these claims 

should be limited to only those 

circumstances in which it is necessary. 

Further discussion on upfront 

substantiation is found in Unit III.E.2. 

In order to assert a claim of 

confidentiality for a plant site identity 

under this amended rule, the submitter 

must check the appropriate box on the 

reporting form indicating a 

confidentiality claim for plant site 

identity and substantiate the claim in 

writing by answering certain questions 

provided in § 710.58(d) of the regulatory 

text. If a submitter fails to substantiate 

the plant site CBI claim, EPA could 

make the information available to the 

public without further notice to the 

submitter. 

b. CBI claims for chemical production 

volume information. EPA did not 

change the ability of the submitter to 

assert a claim of confidentiality for 

production volume information if the 

release of that information would reveal 

trade secrets or confidential commercial 

or financial information as provided by 

section 14 of TSCA. However, 

submitters may now make separate CBI 

claims for both actual plant site 

production volume information and a 

corresponding production volume 

range. Production volume ranges are 

similar to those used in the 

implementation of the original TSCA 

Inventory collection and can be found at 

§ 710.52(c)(3)(v) of the regulatory text. 

In the last four IUR submission 

periods when EPA sought actual 

production volume information, 

approximately 65% of the information 

was claimed as confidential. In contrast, 

only 35% of production volume data 

collected in ranges in the original TSCA 

inventory collection were claimed as 

confidential. This difference indicates 

that submitters may be significantly less 

likely to make CBI claims for production 

volume information reported in ranges 

than for discrete production volume 

figures. The high proportion of CBI 

claims in IUR reports has severely 

limited EPA’s ability to convey 

production volume information to the 

public, even in the form of a national 

aggregate production volume for the 

chemical. EPA needs to be able to 

convey production volume information 

to the public to explain its chemical risk 

assessment and risk management 

decisions. Effective communication of 

this information is vital to EPA’s overall 

mission. EPA has added the ability to 

claim production volume range 

information CBI in an effort to address 

this problem. In some cases, submitters 

may choose to claim their actual 

production volume as CBI, while 

allowing the more general production 

volume range to be made public. 

III. Public Comments 

EPA carefully considered the 

comments it received on the proposed 

IURA. Major comments are discussed 

below. Additional comment summaries 

and more detailed responses are 

contained in the ‘‘Summary of EPA’s 

Responses to Public Comments 

Submitted in Response to Proposed 

TSCA Inventory Update Rule 

Amendments’’ (Ref. 18). 

A. General Comments 

1. How will EPA and others use the 

new exposure-related data collected 

under these amendments? Several 

commenters expressed the view that 

EPA has not provided adequate 

justification supporting the Agency’s 

need for the new IUR data, nor enough 

specific examples showing how EPA 

would use the data for its intended 

purpose. 

EPA has an obligation under TSCA to 

protect human health and the 

environment from unreasonable risks 

associated with chemicals under its 

jurisdiction. In order to evaluate 

potential chemical risks, EPA has 

determined that a portion of the 

chemicals (both inorganic and organic) 

on the TSCA Inventory currently 

warrant the collection of manufacturing 

information, and that a subset of those 

chemicals (i.e., those produced in 

annual quantities of 300,000 lbs. or 

more at a site) currently warrant the 

collection of supplementary processing 

and use information. EPA is amending 

the IUR to provide an accurate and 

readily available source of basic 

exposure-related information for 

approximately 4,000 of the 76,000 

substances listed on the TSCA 

Inventory. The amendments 

significantly limit industry’s reporting 

burden while providing EPA with 

information needed to screen for risks to 

human health and the environment. 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 865

EPA’s primary use of these data will 

be to identify priority TSCA chemicals 

for more detailed information gathering, 

risk assessment, and risk management 

in order to develop targeted programs, 

allowing the Agency to be proactive in 

protecting human health and the 

environment. Screening chemical risks 

generally requires a combination of both 

hazard and exposure information. The 

lack of exposure-related data beyond 

production volume data in the current 

IUR has severely limited the usefulness 

of the current IUR data for risk 

screening. Moreover, the exposurerelated data that will be collected under 

IURA are not otherwise readily available 

from publicly available data sources (see 

Unit III.A.3.). This lack of exposurerelated data has made it difficult for 

EPA and others to identify chemicals 

with potential exposures of concern, 

and has resulted in the generation of 

overly conservative screening level 

exposure assessments. 

The addition of manufacturing, 

processing and use exposure-related 

data to IURA, especially when compiled 

by EPA into a searchable data base 

format, will enable EPA and others to 

more readily screen chemicals for 

exposure and risk. These reviews will 

allow for better prioritization of 

chemicals to identify those warranting 

more detailed assessments and to 

eliminate chemicals of lesser concern 

from further review. 

Data generated by IURA will be used 

in a wide variety of programs 

fundamental to fulfilling the Agency’s 

TSCA statutory mandate. These 

programs range from the more 

traditional existing chemicals risk 

screening efforts, to voluntary programs 

such as EPA’s Design for the 

Environment program (see http://

www.epa.gov/opptintr/dfe), to 

individual requests for analysis of 

chemicals not associated with a 

particular program. The IURA data base 

will be searched to identify chemicals or 

use scenarios meeting specific criteria. 

For instance, the data base could be 

searched to identify chemicals that, 

based upon these data, have the greatest 

potential for consumer exposure, 

creating a list of chemicals arranged 

according to the production volumes 

associated with different consumer uses. 

Additional examples of uses for IURA 

data are provided in this section and in 

EPA’s ‘‘IURA Data Use Plan’’ (Ref. 19). 

The Agency anticipates that, as was true 

even for the basic production data 

reported under the existing IUR, new 

uses of IURA data by EPA and by others 

will continually emerge and cannot be 

predicted at this time. 

Results from EPA tools such as the 

Use Cluster Scoring System (UCSS) will 

be greatly improved by IURA data. The 

UCSS is a computerized tool that 

combines hazard and exposure 

information from a variety of data 

sources, analyzes the data in relation to 

groupings by commercial use, or 

‘‘clusters,’’ and identifies clusters of 

potential concern to EPA. EPA’s Science 

Advisory Board (SAB) commented in its 

evaluation of the UCSS that the lack of 

exposure information in the system has 

impaired its usefulness (Ref. 20). The 

IURA data base will provide exposure 

information that the UCSS will be able 

to download directly and use. (For a 

description of UCSS, see V.B.6. of the 

proposed rule at 64 FR 46780 or 

www.epa.gov/oppt/cahp/actlocal/

use.html) 

EPA will also use IURA data to 

perform preliminary exposure and risk 

screening across a portion of the TSCA 

Inventory chemicals. Some of the same 

types of data that will be collected 

under IURA have been collected under 

the Agency’s TSCA Existing and New 

Chemicals Programs and have aided 

EPA in performing exposure and risk 

screening. These exposure-related data 

were submitted as part of programs such 

as: The voluntary UEIP (see http://

www.epa.gov/opptintr/exposure/docs/

ueip.htm for a description of this 

project) and the PMN program under 

TSCA section 5. Although the UEIP and 

PMN programs involve the submission 

of certain data that are the same as or 

similar to data being submitted under 

IURA, these programs cannot 

sufficiently serve the needs that IURA 

will serve (see Units V.A.1. and V.B.5. 

of the proposed rule at 64 FR 46775 and 

46780). However, these programs are 

examples of the usefulness of certain 

IURA data elements. 

For example, several IURA data 

elements were used in an Existing 

Chemicals Program initial review of the 

chemical methyl ethyl ketoxime 

(MEKO). This review relied in part upon 

data submitted by industry under the 

UEIP. Some of the data are similar to 

those that will be reported under IURA 

and include the following: Production 

volume, manufacturing process, 

industry sector, industrial processing/

use activity, functional use, number of 

sites, number of workers, physical/

chemical properties, and consumer 

product information. Other UEIP 

information submitted by industry on 

MEKO are not of the sort that will be 

collected under IURA, such as 

environmental releases (releases to air, 

water, etc.), worker exposure activities, 

and monitoring data. The IURA is 

designed to obtain information that is 

the most critical for generating 

screening level exposure profiles. 

The UEIP submissions for MEKO 

indicated that there were one 

manufacturer and two importers of 

MEKO in 1993 and five primary end 

uses (submissions provided percentages 

of MEKO production and import 

volumes devoted to each use). The 

submissions also reported the number of 

workers at the manufacturing site, the 

physical forms of products containing 

MEKO, and the MEKO weight fraction 

in each use. 

The MEKO use information was 

combined with information from 

available workplace monitoring studies 

and modeling approaches to compile a 

screening level workplace exposure 

assessment. The UEIP information on 

use provided crucial information to 

allow EPA to postulate process 

operations, worker activities, and 

possible exposures. For example, 

MEKO’s primary use (92% of 

production and import volume) is as a 

paint additive. This fact allows EPA to 

refer to information on paint 

manufacturing and use to estimate 

exposures to workers who either 

formulate paints or apply the paints 

using spray guns or other techniques. 

MEKO use in paint indicates a potential 

for exposure to several large populations 

(workers and consumers) because 

exposure to even small amounts of paint 

can result in significant exposure levels 

to chemicals in paints. Such use 

information can also be used by EPA to 

generate estimated numbers of workers 

in very small businesses (< 10 workers) 

that may be poorly represented by 

existing National Occupation Exposure 

Survey (NOES) data. In the MEKO case, 

such a population would be commercial 

painters. Without the information about 

MEKO use in paints and the large 

percentage of MEKO volume devoted to 

this use, exposed populations and 

exposure level estimates may have been 

severely underestimated or left as a data 

gap (not estimated). Such 

underestimations and data gaps can 

artificially lower the appropriate level of 

concern for potential risk(s) from a 

chemical. 

The usefulness of IURA data elements 

is also demonstrated by EPA’s use of 

similar data in its New Chemicals 

Program. PMNs for new chemical 

substances submitted to EPA under 

TSCA section 5 require many of the 

same exposure-related data elements 

that will be reported under IURA. 

Exposure-related data in PMNs include 

estimates of production volume, 

categories of use, percent production 

volume in the categories of use, 

maximum number of workers exposed, 

866 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

and concentrations and physical forms 

of the chemical. EPA uses these 

exposure-related data to generate 

screening level risk assessments for 

regulatory decision-making under TSCA 

section 5. 

The manufacturer of a new chemical 

provided the following information in a 

recent PMN submission: An estimated 

import volume; chemical uses and the 

percentages of the import volume 

devoted to each use (non-cosmetic 

applications as a component of a 

fragrance formulation used in 

household products such as detergents, 

cleaners, soaps, room fresheners, etc.); 

number of sites and workers; and 

consumer product information (weight 

percent in products). EPA used this 

information in combination with 

technical references and other data to 

estimate the number of manufacturers of 

household products who may use the 

new substance. Releases of the new 

substance as a result of the fragrance 

formulation process and from 

manufacturers of the household 

products were estimated, resulting in 

estimated environmental concentrations 

of the new substance due to its release 

and estimated general population 

exposures to the new substance. EPA 

also used the information on processing 

and use in combination with modeling 

techniques to estimate the number of 

workers and consumers who may be 

exposed to the new substance and their 

estimated exposures to the new 

substance. These exposure-related 

estimates, when combined with 

information on the estimated hazards of 

the new substance, indicated that the 

estimated risks to potentially-exposed 

workers, the general population, 

consumers, and aquatic species were all 

below levels of concern. Therefore, the 

Agency could determine that no further 

regulation under TSCA section 5 was 

needed for this new substance. In 

contrast, without this information, EPA 

would have had to rely on generic 

assumptions for approximating 

potential exposures. These types of 

assumptions are intended to be 

conservative in nature and therefore 

often result in higher than likely 

exposure estimates. 

Information from the IURA may also 

be used in efforts to identify single 

chemicals to support potential exposure 

prevention activities. For example, EPA 

recently learned that certain imports of 

zinc sulfate were contaminated with 

cadmium. Using the IURA processing 

and use data on inorganic substances, 

EPA could have quickly identified 

importers of zinc sulfate and segments 

of industry or the general population 

that might use the chemical. EPA then 

could have targeted warnings of the 

potential for exposure to cadmium more 

effectively, thereby preventing 

exposures to the groups likely to be the 

most highly exposed. 

Other Federal agencies have also long 

recognized the need for and importance 

of exposure data. OSHA, NIOSH, and 

CPSC have written letters supporting 

EPA’s and their own need for exposure 

data (Refs. 12, 13, 21, 22, and 23). In 

May 2000, the Government Accounting 

Office (GAO) stated that ‘‘Various 

federal agencies have collected such 

human exposure data for a number of 

purposes; historically, these collection 

efforts have been limited to selected 

chemicals, subpopulations, and time 

periods’’ (Ref. 24). 

Other government agencies, industry, 

public interest groups, and the public in 

general will be able to access and use 

the non-CBI portion of IURA 

information. The IURA exposure-related 

data will be important to users beyond 

those who accessed the existing IUR in 

the past solely for production volume 

information. The Natural Resources 

Defense Council (NRDC), for example, 

has expressed interest in using IURA 

information (Ref. 25). In another case, 

persons interested in reviewing the HPV 

Challenge Program screening level 

hazard data (see http://www.epa.gov/

opptintr/chemrtk/volchall.htm) will be 

able to use the non-CBI exposure-related 

IURA data to put the hazard data into 

context. Risks identified via evaluation 

of these screening level hazard and 

exposure data then can be addressed. 

Although EPA can envision a wide 

variety of uses for the new IURA 

exposure-related information as 

described in this section, the Agency 

anticipates that even more opportunities 

exist for use of this information, as is 

true for the basic production data 

reported under the current IUR. 

2. What is the practical utility of the 

new exposure-related data? 

Commenters have questioned whether 

the data collected as a part of this 

rulemaking will have ‘‘practical utility.’’

Practical utility is defined in the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3502(11)) to mean ‘‘the ability 

of an Agency to use information, 

particularly the capability to process 

such information in a timely and useful 

fashion.’’ The OMB regulatory 

definition of ‘‘practical utility’’ at 5 CFR 

part 1320.3(l) addresses not only the 

theoretical or potential usefulness of 

information to an Agency, but also its 

actual usefulness, taking into account its 

accuracy, validity, adequacy, and 

reliability, the Agency’s ability to 

process the information in a useful and 

timely fashion, and whether the Agency 

demonstrates actual timely use of the 

data by the Agency’s own functions. 

The following discussion addresses 

commenters’ concerns in two parts: 

First, the accuracy, validity, adequacy, 

and reliability of the data; and second, 

the timely use of the data by EPA. 

a. How has the Agency ensured that 

the data will be accurate, valid, 

adequate, and reliable? Commenters 

asserted that the data EPA proposed to 

collect through IURA would not be 

adequate for the purposes stated by 

EPA, and would not be accurate, valid, 

or reliable. Commenters stated that the 

information collected through IURA 

would be of limited accuracy and would 

be inferior to data the Agency has 

collected in other programs. 

Commenters also stated that the 

information would be so uncertain that 

it would not be useful to predict 

chemical risk, and that there are so 

many other factors that affect exposure, 

such as engineering controls, that the 

data would provide a limited and 

potentially inaccurate view of potential 

exposure. Additionally, commenters 

asserted that they do not know how 

their chemicals are used downstream of 

the manufacturing site, therefore if they 

were required to report such 

information, the resulting data would be 

unreliable. 

EPA considered the types of 

information needed for screening level 

exposure and risk assessments and 

believes the information that will be 

collected through IURA will have the 

necessary level of accuracy, validity, 

adequacy, and reliability for such 

assessments. EPA agrees that there are 

many ways to increase the accuracy, 

validity, and reliability of the data. 

However, in developing IURA and 

considering various alternatives, EPA 

relied on experience from programs 

such as TSCA’s PMN program and the 

UEIP data collection, and maintained a 

balance between data needs for 

exposure screening and priority setting 

and the burden associated with 

providing the information. If the Agency 

had required very precise, specific 

reporting, submitter burden would have 

increased beyond that which is 

appropriate for a screening level data 

collection. EPA also agrees that there are 

many factors that can affect exposure 

potential; however, the data provided by 

the submitters will provide baseline 

information sufficient for an initial 

screen of exposure potential. 

i. Adequacy of the data. Before 

proposing the IURA, EPA analyzed 

various exposure data collections and 

assessments to determine the data 

elements needed for a screening level 

exposure assessment. This discussion 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 867

and analysis are in the document 

‘‘Inventory Update Rule (IUR) 

Amendment Technical Support 

Document: Exposure-Related Data 

Useful for Chemical Risk Screening’’

(Ref. 14). Commenters’ suggestions on 

the proposed rule implied that more 

extensive information about exposures 

than was included in the proposed rule 

would be necessary for even a screening 

level analysis of potential exposure. One 

commenter stated that there are many 

other factors that can significantly affect 

the potential for exposure. These factors 

include engineering controls and 

personal protective equipment 

practices, the nature of the activities in 

which workers are engaged, and the 

physicochemical characteristics of the 

chemical substances. This commenter 

also stated that the data collected under 

IURA will provide a limited and 

potentially inaccurate view of potential 

exposure. However, as summarized in 

Unit III.A.1., risk analyses performed by 

the Agency in general and OPPT in 

particular are graduated and datadriven. As the initial levels of concern 

and the quantity and quality of data 

increase, the need for methodologies 

used in risk review become more 

detailed and exacting, and the reviews 

become more accurate and reliable. 

Based on its experience screening 

chemical risks through such programs 

as the TSCA New Chemicals Program, 

the Agency believes IURA data will 

provide information adequate to 

perform initial screens of chemicals. 

The Agency also will be better able to 

prioritize and make basic risk 

management decisions about those 

chemicals of greatest concern as 

indicated by the available data. These 

better informed decisions will enhance 

confidence that the most appropriate 

chemicals are selected for more detailed 

assessments. 

ii. Accuracy and reliability of the 

data. The Agency considered the data 

accuracy and reliability needed for 

screening level exposure analyses, and 

took several steps to ensure IURA data 

meet those needs. Screening level data 

need not be absolutely precise, but 

should be accurate and reliable enough 

to make usable and defensible technical 

assessments. The IURA will supply 

exposure-related information the 

Agency currently does not have, 

recognizing that industry has a greater 

knowledge than EPA about its own 

operations and the uses of chemicals it 

manufactures and sells. Without this 

information, EPA either would not 

screen these chemicals, would screen 

them using outdated or anecdotal 

exposure information, or would rely on 

exposure estimates (typically 

conservative) using modeling data. 

Commenters stated that the accuracy 

and reliability of much of the 

information reported in Part III of the 

proposed revised Form U (§ 710.32(c)(4) 

of the proposed regulatory text, now 

§ 710.52(c)(4)) would be highly 

questionable because it relates to sites, 

activities, and products that are not 

under the direct or indirect control of 

the reporting company. Industry 

programs such as the ACC’s Responsible 

Care Program (see http://

www.americanchemistry.com for more 

information) require that, as part of the 

program, member companies work with 

customers, carriers, suppliers, 

distributors, and contractors to foster 

the safe use, transport and disposal of 

chemicals. The Responsible Care 

Program, coupled with basic marketing 

and sales force activities, suggests that 

many companies are well informed 

about downstream uses of their 

chemicals. EPA recognizes that 

submitters may not always have 

detailed information about how the 

chemical(s) they make are used. As a 

result, submitters will only be required 

to report this information to the extent 

it is ‘‘readily obtainable’’ (see Unit 

II.F.6.b.). In addition, the Agency 

believes, based on its experience with 

the New Chemicals Program, the UEIP, 

stakeholder meetings, discussions with 

industry about voluntary risk 

management programs, and industry’s 

various self-regulation initiatives, that 

most submitters have at least some basic 

information about downstream uses, 

such as the information that will be 

reported under the IURA. These data are 

believed to be of sufficient reliability for 

use by the Agency and others for 

purposes such as screening level risk 

assessments and prioritization. 

EPA also requires much of the IURA 

information to be submitted in EPA 

specified ranges. This requirement 

benefits both the Agency and 

submitters. First, range reporting is less 

burdensome for the submitter than 

calculating specific numeric estimates. 

Demanding greater data accuracy 

increases the burdens associated with 

data collection. Second, information 

reported in discrete numeric values can 

indicate a level of accuracy that is not 

necessarily present. EPA believes that a 

higher level of confidence in data 

accuracy can be achieved by specifying 

ranges. 

Commenters suggested that EPA use 

other methods to obtain processing and 

use information, such as voluntary data 

collection programs. However, 

voluntary industry efforts are not 

uniformly reliable for collecting data, 

and the Agency generally cannot ensure 

that data submitted under voluntary 

efforts will be complete and accurate. 

For example, the UEIP was undertaken 

by EPA in partnership with industry to 

collect relatively detailed information 

on 60 high production volume 

chemicals. EPA received data for 48 of 

the 60 UEIP chemicals. Many of the 

forms received for those 48 chemicals 

were not completely filled out, and only 

a subset of manufacturers submitted 

data. Thus, while the information that 

EPA received was quite useful, it was 

insufficiently complete for the purposes 

to which IURA information will be put. 

EPA’s experience with UEIP is an 

indicator that exposure data collected 

under a voluntary effort are likely to be 

uneven and fall short of meeting EPA’s 

needs. 

iii. Validity of the data. Another 

commenter had specific concerns about 

the validity of the worker exposure data 

and felt that an auditing program would 

be necessary to generally ensure an 

acceptable level of quality for data 

collected under IURA. 

EPA agrees that validated exposure 

data are the most useful for the full 

range of Agency risk assessment 

activities. However, EPA’s experience 

with similar data collection efforts such 

as TSCA’s New Chemicals Program 

demonstrates that the type of data EPA 

is collecting under IURA are sufficient 

for the purpose of screening to prioritize 

follow-on efforts for risk assessment and 

management. A rigorous validation 

process for all IURA exposure-related 

information would impose significant 

additional burdens on industry and the 

Agency that would likely outweigh the 

benefits accruing to the screening 

process. As discussed in Unit III.A.1., 

EPA exposure and risk evaluations are 

often iterative, with screening level 

assessments succeeded by more 

intensive and data rich assessments, as 

indicated by the screening level 

assessments and as data become 

available. The IURA data will be useful 

to the Agency in evaluating potential 

exposures and risks, serving as 

indicators as to what levels and types of 

exposures from which chemicals need 

further review. 

b. Will the Agency use the data in a 

timely manner? Many commenters 

questioned whether EPA would be able 

to make effective and timely use of 

IURA processing and use information, 

stating that the large amount of data 

submitted would overwhelm the 

Agency. EPA acknowledges that IURA 

will generate a significant quantity of 

new data that EPA has not handled 

under past IUR data collections. 

However, EPA has carefully designed 

868 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

the data collection to facilitate efficient 

data management and use. Data 

collected through IURA will be put into 

a relational data base format, which can 

be easily searched, compared, and used. 

The collection of data organized by 

codes, rather than narrative information 

presented in an unstructured manner, 

lends itself to such a data base format. 

In addition, providing for electronic 

IURA submissions allows data to be 

entered into the data base more 

accurately and expeditiously, resulting 

in a quick turnaround between the 

submission of the data to the Agency 

and the availability of the data for use. 

The Agency anticipates that 

approximately 95% of all reports will be 

submitted electronically or on disks, as 

opposed to hard copies. This compares 

with 70% that were submitted on disks 

in 1998. The IURA will facilitate EPA’s 

information management and the data 

will be available quickly for the 

Agency’s and others’ use. 

3. Why doesn’t EPA use other 

available sources of data or mechanisms 

to collect the data sought under IURA? 

EPA requested comments on specific 

mechanisms or data sources it could use 

to obtain needed exposure-related 

information with greater ease and less 

burden to industry. Commenters 

responded with a variety of sources, 

ranging from current data collection 

mechanisms within EPA (such as TSCA 

8(a) PAIR, UEIP, and cooperative 

approaches) to public data sources such 

as the Hazardous Substances Data Bank 

(HSDB) (HSDB is a toxicology data file 

on the National Library of Medicine’s 

(NLM) Toxicology Data Network 

(TOXNET)). In addition, many 

commenters stated that EPA has not 

made effective use of the exposurerelated data it has collected already 

under current or prior programs. For 

example, they stated that data collected 

under two other TSCA rules - the PAIR 

and the Comprehensive Assessment 

Information Rule (CAIR) rules - have not 

been used effectively to support Agency 

risk assessment or risk management 

decisions. Commenters went on further 

to say that under the voluntary UEIP, 

EPA was furnished exposure-related 

data on 60 HPV chemicals (actually only 

48), but only two reached the initial risk 

assessment stage. 

The alternate data sources 

commenters described were generally 

sources that EPA had already evaluated 

in its analysis for the proposed rule or 

with which EPA was otherwise familiar. 

EPA explored a wide variety of public 

data sources, as demonstrated in the 

following: ‘‘Inventory Update Rule (IUR) 

Amendments Technical Support 

Document: Exposure-Related Data 

Useful for Chemical Risk Screening’’

(Ref. 14), ‘‘Economic Analysis of 

Proposed Amendments to the TSCA 

Section 8 Inventory Update Rule’’ (Ref. 

26), and ‘‘A Review of Existing 

Exposure-Related Data Sources and 

Approaches to Screening Chemicals: A 

Response to CMA’’ (Ref. 27) (see also 

Unit V.B.5. of the proposed rule at 64 

FR 46780)). For the most part, 

commenters did not identify new 

sources or provide additional 

information to support the assertion that 

these alternate data sources provide the 

information that EPA proposed to 

collect under IURA. After considering 

the information provided, EPA believes 

the decision not to use an alternate data 

source as a replacement for IURA is still 

sound. The Agency may, however, 

evaluate an alternate source for 

individual chemicals as part of its 

consideration of a particular chemical 

under the new exemption process 

established in the final rule. 

EPA has spent considerable effort and 

resources evaluating other data sources 

that could potentially provide the 

accurate and up-to-date information that 

the Agency needs. A primary 

consideration, as mandated by TSCA, 

was not to subject industry to 

unnecessary or duplicative reporting. 

The exposure information sought under 

IURA is not currently accessible to EPA. 

Although some useful exposure-related 

data exist in some sources, the data are 

insufficient for the purposes to which 

IURA data will be put, typically because 

they are neither timely or detailed 

enough. Without IURA, EPA has 

difficulty efficiently screening potential 

risks posed by approximately 4,000 

higher production chemicals on the 

TSCA Inventory. 

Commenters stated that, if EPA were 

to have specific concerns about 

information collection for substances or 

categories of substances, the selective 

use of TSCA section 8(a) PAIR (40 CFR 

part 712) reporting would be more cost 

effective than requiring all 

manufacturers exceeding a production 

trigger to report manufacturing, 

processing, and use information. EPA 

disagrees with the suggestion that PAIR 

rules would be an efficient or cost 

effective way to compile a data base to 

allow the relatively large-scale risk 

screening of chemicals on the TSCA 

Inventory. PAIR is a very useful data 

collection tool when one or a small 

group of chemicals is targeted for risk 

assessment; however, PAIR is limited 

when collecting information on a large 

number of chemicals. Additionally, the 

PAIR rule has fewer, less definitive data 

elements than IURA, is a one-time 

collection versus the recurring 

collection of IURA, and will not provide 

data sufficient to meet the goals of 

IURA. Use of PAIR rather than IURA 

would force EPA to set risk screening 

priorities based on hazard and 

production volume alone, or in response 

to requests from others. As discussed in 

the document entitled ‘‘A Review of 

Existing Exposure-Related Data Sources 

and Approaches to Screening 

Chemicals: A Response To CMA’’ (Ref. 

27), this approach greatly hinders EPA’s 

ability to make effective and efficient 

risk management decisions. 

EPA plans to continue using existing 

data sources and information sets. For 

example, EPA has used data previously 

collected under PAIR, CAIR, and the 

UEIP in a variety of ways, such as to 

support TSCA section 4 test rule 

analyses, to provide analyses for the 

Agency’s efforts under the OECD SIDS 

program, and in support of international 

efforts (Refs. 18 and 27). However, the 

existing sources are generally best used 

when conducting a more detailed risk 

assessment of a specific chemical of 

concern, rather than preliminary risk 

screening of a relatively large set of 

chemicals. The IURA submissions will 

provide a consistent set of screening 

level exposure data that will allow EPA 

to better identify on a relative basis the 

chemicals of highest priority for further 

risk evaluation. EPA will use IURA data 

to identify those specific chemicals 

which are of potential concern and need 

follow up assessment. For instance, 

IURA exposure data integrated with 

HPV Challenge Program hazard data 

will provide the input needed to 

effectively develop risk-based priorities 

for more detailed assessment of 

chemicals. Once EPA has determined 

that a specific chemical (or group of 

chemicals) has sufficient potential for 

exposure or risk to warrant further 

assessment, the Agency will use the 

other information sources and data 

gathering tools as appropriate. 

4. Can TSCA information be used for 

right-to-know purposes? Some of the 

commenters stated that TSCA does not 

authorize EPA to promulgate IURA 

based in part on EPA’s goal of providing 

‘‘right-to-know’’ information to the 

public, non-governmental entities and 

private organizations. In addition, some 

commenters noted that OSHA and other 

agencies have their own authorities to 

collect information on chemicals. 

TSCA contains many of the principles 

embodied in the right-to-know concept. 

For instance, TSCA section 14(b) 

specifically authorizes EPA to disclose 

health and safety data collected under 

the statute. TSCA section 14 reflects the 

legislative determination that certain 

TSCA data should be available to the 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 869

public and interested parties. In 

addition, sections 4, 5, 6, as well as 

section 21, for example, provide 

opportunities for public participation in 

chemical management decisions. 

Participation must be meaningful, and 

to be meaningful the public must have 

access to TSCA non-confidential 

information. 

TSCA was designed in part to address 

the lack of health, safety, and exposure 

information government agencies and 

the public faced in dealing with 

chemicals. See, H.R. Rep. 94-1341 at 6 

(1976), reprinted in Legislative History 

of the Toxic Substances Control Act, at 

414 (1976) (‘‘Present authorities for 

protecting against and regulating 

hazardous chemicals are fragmented 

and inadequate . . . Most significant 

among the deficiencies are . . . (3) No 

authority exists for collection of data to 

determine the totality of human and 

environmental exposure to chemicals.’’). 

TSCA was seen as a way of providing 

federal agencies and the public with 

access to health, safety, and exposure 

data so that the risks of chemical 

substances could be more fully 

evaluated and understood. See, 

Statement of Sen. Hartke, Cong. Rec., 

March 26, 1976 [S4397- 4432], reprinted 

in Legislative History of the Toxic 

Substances Control Act, at 218 (1976) 

(‘‘[T]he essential element of this 

legislation is that it has attempted to 

provide for the individual- not only who 

works, but for the rest of American 

society- the right to know what is in 

store as far as the toxicity of the 

chemicals is concerned.‘‘). Congress 

envisioned TSCA as a tool for providing 

the public and others with health, 

safety, and exposure information about 

chemical substances. 

Finally, TSCA does not limit the use 

or disclosure of data (except if data are 

considered confidential) collected under 

the statute. Congress drafted TSCA in 

part to provide basic health, safety, and 

exposure information to other federal 

agencies, as well as state, local and 

international governments. TSCA 

provides several mechanisms--TSCA 

sections 9, 10, and 12 for example--for 

sharing health and safety data among 

various levels of government. These 

sections again demonstrate TSCA’s role 

as a tool for gathering and disseminating 

information about chemicals. 

B. Comments on Specific Data Elements 

1. Manufacturing information—a. 

Physical form. EPA requested comment 

on its proposed requirement that 

submitters report the physical form of a 

chemical as it leaves the site of 

manufacture. Several commenters 

suggested variations on the specifics of 

physical form reporting, but generally 

agreed with reporting the physical form 

as the chemical leaves the site of 

manufacture. For instance, one 

commenter suggested expanding the 

types of physical forms that can be 

reported. EPA has determined that the 

six categories as proposed (see 

§ 710.52(c)(3)(viii) of the regulatory text) 

will be adequate for risk screening 

purposes, and is not adding additional 

physical form categories at this time. 

Experience with the same six physical 

form categories as part of EPA’s 

exposure screening assessment of over 

20,000 chemicals in its New Chemicals 

Program indicates that the categories of 

physical forms that EPA is using under 

IURA will be adequate. 

Other commenters recommended that 

EPA allow submitters to report more 

than one physical form for each 

reportable substance, because a 

substance may leave a site in more than 

one physical form. EPA agrees with this 

comment and is requiring in this final 

rule that submitters report all physical 

forms of a substance when the substance 

is sent off-site. Reporting on all physical 

forms in IURA will lead to a better 

assessment of exposure to a chemical 

substance. For example, processing a 

fine, nonagglomerating powder could 

result in occupational exposure by 

inhalation of chemical dust. Processing 

the same chemical as a liquid solution 

would eliminate, or at least reduce, the 

inhalation risk (the liquid could become 

an aerosol and be inhaled, depending on 

the processing activity). By combining 

data elements on the physical form of a 

chemical substance, its production 

volume, and the fraction directed to 

each industrial processing or use 

activity, a screening estimate of the 

potential exposure associated with 

manufacturing or processing of a 

chemical substance can be derived. The 

resulting exposure assessment will be 

more representative and less 

conservative than if the physical form(s) 

were unknown. For these reasons, EPA 

is requiring the reporting of all physical 

forms in which a chemical substance 

leaves the manufacturing site. 

b. Concentration. EPA originally 

proposed to require the reporting of 

both maximum and average 

concentrations of each reportable 

chemical substance at the time the 

substance is sent off-site. A number of 

commenters felt that this information 

would be difficult to report for the 

following reasons: Chemicals may be 

used in many product formulations at a 

given plant site and there may often be 

no consistent average or maximum 

concentration of an individual chemical 

across these formulations; such 

information does not reside in any 

currently available data bases and 

would need to be generated for IURA 

reporting (which would be particularly 

difficult with respect to average 

concentration information); and average 

and maximum concentrations may vary 

in product formulations during different 

IURA reporting cycles. Commenters 

suggested that maximum concentration 

information will be misleading if only a 

small amount of the reportable chemical 

substance is made available 

commercially at that concentration, 

while the bulk of the total quantity 

leaving the site has a lower 

concentration. They also indicated that 

determining average concentration 

requires a complicated calculation 

which falls outside the scope of 

‘‘reasonably ascertainable’’ information. 

Commenters suggested that average 

concentration can be calculated by 

product or by the weighted average of 

each product, and each of the 

calculations can result in tremendously 

different answers. 

The Agency has determined that 

average concentration information is not 

critical for purposes of screening level 

exposure assessment and has not 

included this element in this final rule. 

Screening level review is typically 

meant, in part, to serve as a method of 

identifying chemicals that even at their 

maximum concentration are less likely 

to present a risk to human health or the 

environment. Average concentration 

information cannot be used to make 

such a determination. 

EPA recognizes that the concentration 

of an IUR reportable chemical may vary 

from shipment to shipment leaving a 

submitter’s site, or when reacted on-site 

to produce a different chemical 

substance. However, maximum 

concentration is to be reported in wide 

ranges and not specific numbers, 

thereby alleviating the need to 

determine specific concentrations. 

Additionally, EPA does not intend for 

submitters to go to great lengths to 

determine what maximum 

concentration ranges to select for IUR 

reporting. Instead, EPA is simply 

requiring that submitters select a range 

of concentrations from a list of given 

ranges. The ranges from which 

submitters must select are: Less than 1% 

by weight; 1–30% by weight; 31–60% 

by weight; 61–90% by weight, and 

greater than 90% by weight. 

One commenter was concerned that 

EPA did not specify whether it would 

require submitters to conduct specific 

chemical testing or statistical analysis in 

order to report concentration data, or 

whether submitters should merely 

estimate concentrations. In addition, the 

870 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

commenter was unsure whether a 

submitter should report the maximum 

concentration level for each product it 

manufactures/imports, or simply 

estimate the overall maximum 

concentration of the chemical 

substance. EPA recognizes that 

concentration data may vary from 

product to product and from shipment 

to shipment, and may be difficult to 

report in some instances, particularly in 

product formulations. EPA is not 

requiring the reporting of concentrations 

in all products and formulations but 

rather only one maximum 

concentration, regardless of the 

chemical substance’s physical form(s) or 

product formulation(s). Because 

concentration information will be 

reported in ranges and not as individual 

values, this information or at least an 

estimate should be known to or 

reasonably ascertainable by most 

submitters. Submitters are not expected 

to conduct chemical testing or statistical 

analysis beyond any testing or analyses 

already done by the submitter as part of 

normal operations in order to report 

maximum concentration information. 

EPA anticipates that chemical importers 

will frequently receive maximum 

concentration information from their 

suppliers, and manufacturers will 

obtain this information from samples 

analyzed for quality control. This 

information is often found in the 

physical property or hazardous 

constituents sections of the MSDS. 

2. Industrial processing and use. The 

Agency received three comments 

regarding the IFCs to be reported by 

submitters that have plant sites at which 

300,000 lbs. or more of a reportable 

chemical substance are manufactured. 

The first comment questioned how the 

IFCs would apply to chemicals with 

multiple industrial uses. The second 

comment suggested that the Agency 

provide submitters with a ‘‘free 

response’’ option if their industrial 

function is not represented among the 

IFCs. The third comment stated that the 

IFCs proposed by EPA were adequate. 

Submitters are required to report up 

to 10 unique combinations of processing 

or use categories, IFCs, and NAICS 

codes (see § 710.52(c)(4)(i)(A), 

(c)(4)(i)(B), and (c)(4)(i)(C) of the 

regulatory text). In making their 

selection from among the IFC codes, 

submitters must determine which IFC 

best represents the specific industrial 

use of the reportable chemical within a 

given NAICS code/processing and use 

category. The Agency will provide 

examples of how to select which code 

‘‘best represents’’ an industrial use in 

the instruction manual that will be 

available to all submitters (see § 710.59 

of the regulatory text). Submitters may 

report multiple IFCs for the same NAICS 

code, and multiple NAICS codes may be 

paired with the same IFC. Unit II.F.7. 

provides further information on 

reporting industrial processing and use 

information. 

The set of IFCs adopted by EPA at 

§ 710.52(c)(4)(i)(C) encompasses the vast 

majority of uses for chemicals subject to 

IUR reporting. Rather than include all 

possible industrial functions, EPA 

selected categories based upon 

information developed due to other 

Agency programs such as the TSCA 

New Chemicals Program and believes 

that the categories included in this final 

rule are sufficient for initial risk 

screening purposes. One commenter 

suggested that the submitter be allowed 

to supply a ‘‘free response’’ for an 

industrial function that is not on the 

EPA list. However, a ‘‘free response 

option’’ could result in a wide array of 

answers, which EPA would then have to 

group. The Agency believes the 

chemical manufacturer is best equipped 

to determine with which industrial 

function scenario the industrial 

processing and use data should be 

matched. If none of the categories fit, 

however, the submitter could report the 

‘‘other’’ category. By aggregating similar 

uses under a single NAICS and a single 

IFC code, EPA will be able to more 

effectively characterize the risk 

associated with the totality of the 

production of each chemical substance. 

By requiring the submitter to identify 

the appropriate IFC code(s) from the 

provided list, EPA seeks to minimize 

the errors that could occur if the 

Agency, rather than the submitter, 

attempted to aggregate uses other than 

those identified in the prescribed list of 

IFCs. 

3. Commercial and consumer use—a. 

Commercial and consumer product 

categories. In the proposed rule, the 

Agency requested comment on the 

appropriateness of the commercial and 

consumer product categories. 

Commenters had a range of opinions 

about the proposed categories. One 

commenter felt that EPA should adopt 

the use categories used by the European 

Commission (EC) (Ref. 28). Another 

commenter stated that the categories 

appeared to be adequate. A third 

commenter suggested that the ‘‘C-19 

Other’’ category be deleted and that the 

Agency consider requiring the submitter 

to identify the specific use. 

EPA is not changing the commercial 

and consumer product categories at this 

time, although the Agency may revisit 

these categories in the future should a 

need arise for more specific commercial 

and consumer use information. EPA has 

evaluated the EC’s set of use categories 

and has determined that these categories 

blend functional use information with 

end use information. They therefore 

constitute a more complex identification 

system than the one that will be used 

under IURA. For the screening level 

purposes of IURA data, EPA currently 

believes that focusing on end use 

information alone for commercial and 

consumer uses provides the necessary 

level of detail for its screening level 

reviews. EPA is concerned that the use 

of EC’s scheme for the commercial and 

consumer reporting would be overly 

burdensome for the current needs 

identified by EPA, due to the greater 

number of categories (55 EC categories 

versus 19 IURA categories). Further 

guidance on the relationship between 

EC and IURA categories can be found in 

the instruction manual for IURA (see 

§ 710.59 of the regulatory text) (Ref. 9). 

In addition, the EC system does not 

appear to describe the commercial or 

consumer end uses in a way that meets 

the needs identified by EPA and 

targeted by IURA. For example, a 

chemical that is used as a propellant 

would be listed under the category 

‘‘aerosol propellants’’ using the EC 

system. Such a listing would not 

provide the Agency with the 

information it needs about the type of 

commercial/consumer product in which 

the submitter uses the propellant (e.g., 

paint, a lubricant). For more information 

on EPA’s commercial and consumer 

category analysis, see the document 

‘‘Inventory Update Rule (IUR) Technical 

Support Document Selection of 

Consumer and Commercial End-Use 

Categories’’ (Ref. 29). EPA will provide 

examples of the types of products that 

fit into its commercial and consumer 

product categories in the instruction 

manual that will be made available to 

all submitters (see § 710.59 of the 

regulatory text). 

EPA considered requiring submitters 

to identify the specific use of the 

product, rather than the use a 

miscellaneous ‘‘Other’’ category. 

However, the Agency prefers to require 

submitters to choose from among the 

commercial and consumer product 

categories provided at 

§ 710.52(c)(4)(ii)(A) of the regulatory 

text in order to encourage manufacturers 

to more carefully consider the listed 

categories, as opposed to being allowed 

to provide their own specific 

description. In this manner, EPA can 

more effectively assign chemicals to the 

correct categories, and avoid guessing 

the appropriate categories because the 

Agency believes the chemical 

manufacturer is best equipped to 

determine with which commercial or 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 871

consumer category their product use 

best fits. By aggregating similar product 

categories, EPA will more effectively 

characterize the risk associated with the 

totality of the use of each chemical 

substance. Requiring the submitter to 

identify the appropriate product 

categories from the provided list will 

minimize the errors that could occur if 

the Agency, rather than the submitter, 

attempted to aggregate uses other than 

those identified in the prescribed list of 

product categories. 

b. Non-TSCA end uses. Three 

commenters requested that EPA not 

only continue to exempt chemicals that 

are manufactured only for non-TSCA 

purposes (such as pesticides, drugs, 

cosmetics, etc.) from all IURA reporting, 

but also exempt manufacturers of IURAreportable TSCA chemicals from the 

requirement that non-TSCA 

downstream uses be reported (such as 

use of a TSCA chemical by a 

downstream processor in making a 

pesticide, etc.). These commenters 

assert that EPA does not have authority 

under TSCA to implement requirements 

of this sort. 

EPA agrees that substances that are 

manufactured only for non-TSCA 

purposes, as described in TSCA section 

3(2)(B), are exempt from all TSCA 

requirements and are not subject to 

reporting under IURA. Therefore, 

substances that are intended at the time 

of manufacture to be used for non-TSCA 

purposes (e.g., as a pesticide, as a drug) 

do not have to be reported. 

The Agency also agrees that 

submitters under IURA will not be 

required to report on the non-TSCA 

downstream uses of the TSCA 

chemicals that they manufacture. It is 

important to note that EPA was able to 

reach this conclusion without reaching 

the issue of whether it has the authority 

to require such reporting. Descriptions 

of IFCs (see § 710.52(c)(4)(i)(C) of the 

regulatory text) have been clarified to 

reflect the fact that they only include 

TSCA uses. For example, one of the 

IFCs is called ‘‘Agricultural chemicals 

(non-pesticidal).’’ The consumer and 

commercial product categories (see 

§ 710.52(c)(4)(ii)(A) of the regulatory 

text) are also restricted to TSCA uses. 

An example of one of these categories is 

‘‘Lawn and garden products (nonpesticidal).’’ This category includes 

chemicals such as compressed gasses in 

delivery systems for many pesticides 

used indoors and outdoors, and other 

intermediates, but does not include 

pesticides. Additionally, many lawn 

amendments such as fertilizers contain 

chemicals that may be regulated under 

TSCA, (e.g., surfactants). 

c. Exempt reporting of use 

information for chemicals in articles. 

Two commenters believed that to the 

extent a submitter’s reportable chemical 

is used in an article, the submitter 

should be exempt from the reporting of 

consumer and commercial end-use 

information (i.e., § 710.32(c)(5) of the 

proposed regulatory text). The 

commenters stated that there is no 

reason to believe that consumer 

exposure will result from chemicals in 

articles. 

EPA does not agree that 

manufacturers of chemicals that are 

later incorporated into articles should 

be exempt from the reporting of 

consumer and commercial end-use 

information. Certain exposures do result 

from chemicals incorporated in articles. 

For example, potential dermal and 

inhalation exposures occur from 

chemicals incorporated into products in 

the category ‘‘fabrics, textiles and 

apparel.’’ Specific cases, such as 

formaldehyde from pressed wood 

products used in mobile homes or 

chlorinated flame retardants used on 

children’s sleep wear, also demonstrate 

that potentially harmful exposures can 

occur from chemicals incorporated into 

articles. 

d. Usefulness of percent production 

data and maximum concentration data. 

A commenter felt that in the case of 

consumer products in particular, it is 

unclear whether the percent production 

data and maximum concentration data 

required under § 710.32(c)(5)(i)(B) and 

(c)(5)(i)(C) of the proposed regulatory 

text would add any material information 

to the production volume information 

already required under the existing IUR. 

The commenter stated that the volumes 

of chemicals they will report as having 

been manufactured, and for which they 

will report maximum concentration 

information, are in the products the 

commenter sells. Therefore, the Agency 

will already have the needed production 

volume and concentration information 

and does not need to collect these 

particular data elements for consumer 

products. 

Production volume and concentration 

information reported at the 

manufacturing site is typically different 

information than percent production 

volume and concentration in consumer 

and commercial categories. Often 

manufacturers will sell a chemical for 

multiple uses, in a variety of products, 

or the chemical will be used multiple 

times before reaching the consumer/

commercial product. For instance, a 

manufacturer may report that a 

chemical is used in three different 

commercial and consumer product 

categories—20% of the manufactured 

production volume is used in category 

A, 35% in category B, and 45% in 

category C. Additionally, while the 

manufacturer sells the product at a 

certain concentration (say 90%), a final 

product may have a different 

concentration. For instance, the final 

product may contain only 5% of the 

chemical. The resulting potential 

exposure scenario associated with such 

a product would be very different from 

a scenario where the concentration in 

the final product is 90%. The Agency, 

therefore, is retaining the commercial 

and consumer percent production 

volume and maximum concentration 

data elements. 

4. General data elements comments—

a. Workers who are ‘‘reasonably likely to 

be exposed’’ to a reportable chemical. 

EPA requested comment on alternative 

definitions of ‘‘potentially exposed 

worker’’ and ‘‘reasonably likely to be 

exposed.’’ Specifically, EPA requested 

comment on whether OSHA definition 

of ‘‘employee’’ in its hazard 

communication standard (29 CFR 

1910.1200(c)) is more appropriate for 

use in IURA. The hazard 

communication standard defines 

‘‘employee’’ as a worker who may be 

exposed to hazardous chemicals under 

normal operating conditions or in 

foreseeable emergencies. Workers such 

as office workers or bank tellers who 

encounter hazardous chemicals only in 

non-routine, isolated instances are not 

covered. OSHA’s hazard 

communication standard also defines 

‘‘exposure’’ or ‘‘exposed’’ as the 

exposure of an employee to a hazardous 

chemical in the course of employment 

through any route of entry (inhalation, 

ingestion, skin contact or absorption, 

etc.) and includes potential (e.g., 

accidental or possible) exposure. 

One commenter stated that OSHA’s 

definition of an employee is appropriate 

to identify persons reasonably likely to 

be exposed to chemical substances. This 

commenter stated that the Agency 

should broaden the definition of 

exposure in IURA to include potential 

(accidental or possible) exposures to 

chemical substances which workers 

may experience in the course of their 

employment. This commenter also 

stated that this is what worker exposure 

entails in the real world and to exclude 

some portion of those worker exposures, 

as EPA proposed, is inappropriate. A 

second commenter felt that persons who 

could be exposed to a chemical 

substance in foreseeable emergencies 

should be included in EPA’s new 

definition for persons who are 

reasonably likely to be exposed to a 

reportable substance. 

872 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

EPA has determined that the OSHA 

definition of ‘‘employee’’ does not 

provide a more appropriate standard 

than the one proposed and finalized in 

IURA. Whereas OSHA wanted to 

provide all persons who could 

foreseeably be exposed to a chemical 

substance with knowledge of the 

potential hazards of that chemical, EPA 

is seeking to specifically identify those 

persons routinely exposed to chemical 

substances and for whom engineering 

controls and personal protective 

equipment are likely to provide the 

greatest benefit. The definition adopted 

by EPA for a person ‘‘reasonably likely 

to be exposed’’ in this rule will target 

those individuals who routinely have 

the potential to be exposed to chemical 

substances, and for whom chronic risks 

are greatest. This definition provides 

more useful and realistic information for 

the risk screening purposes for which 

EPA envisions IURA data will be used. 

b. Personal protective equipment. EPA 

requested comment on whether the 

Agency should collect information on 

the use of PPE during the manufacture 

of chemicals reported under IURA. 

Several commenters stated that EPA 

should not collect PPE information for 

the purposes of risk screening. After 

reviewing these comments, EPA agrees 

that collecting information on the 

availability of PPE would not enhance 

the initial risk screening process, and 

has determined that this data element 

should not be added to the IUR as part 

of this rulemaking. Because EPA cannot 

ensure that protective equipment will be 

available to all employees and, if 

available, will be used properly in a 

well managed hygiene program, the 

potential risk encountered in the 

manufacture, processing, or use of a 

chemical substance is initially assessed 

by EPA in the absence of PPE 

information. The IURA is designed 

primarily to collect only screening level 

information. Inclusion of PPE in risk 

assessment would require collection 

and integration of location-specific 

information on physical conditions and 

the PPE used, and would greatly 

complicate the risk assessment. This 

type of information is more likely to be 

included in assessments more detailed 

than the initial risk screening 

assessment for which IURA information 

will be used. 

A commenter suggested that EPA use 

PPE information as a way to submit 

lower estimates for various IUR data 

elements, such as the number of 

workers. For the reasons provided in the 

previous paragraph, EPA will not use 

PPE information to lower the estimates 

of workers reasonably likely to be 

exposed. Because the reporting of PPE 

information would not contribute to the 

initial risk screening process and would 

impose an additional burden on persons 

reporting under IUR, EPA is not 

including information on PPE in the 

reporting requirements for this rule. 

c. Metric system reporting. Under IUR, 

data are currently reported using the 

U.S. customary system of measurement 

units (e.g., pounds and yards). EPA 

requested comment on changing 

reporting requirements to require metric 

system reporting instead (e.g., kilograms 

and meters). Two commenters suggested 

that EPA convert to metric system units 

or at least give submitters the option of 

using either metric or U.S. customary 

units. One commenter requested that 

EPA continue to require the use of U.S. 

customary units or give submitters the 

option of reporting in either metric or 

U.S. customary units. EPA has decided 

to continue to require the use of the U.S. 

customary system because at least in the 

short term, this allows the IUR data base 

to remain compatible with other Agency 

data bases, especially TRI, which also 

typically use the U.S. customary system. 

EPA believes allowing for reporting 

using either the U.S. customary or 

metric systems of units would create 

confusion and increase reporting and 

administrative error. EPA may revisit 

this issue in future IUR amendments. 

C. Reporting Universe Comments 

EPA received a variety of comments 

concerning which chemicals and sites 

should be subject to reporting and 

recordkeeping requirements. 

1. Chemical categories undergoing 

changes in reporting status. In the IURA 

proposal, EPA created exemptions from 

reporting for several groups of 

chemicals that would otherwise be IURreportable. The IUR currently contains 

full reporting exemptions for inorganic 

chemicals, polymers, microorganisms, 

and naturally occurring chemicals. EPA 

proposed to modify these exemptions 

by: (1) Requiring partial reporting for 

inorganic chemicals in lieu of the 

existing full exemption; (2) creating a 

partial reporting exemption for chemical 

substances termed ‘‘petroleum process 

streams’’ for purposes of reporting 

under IURA; and, (3) creating a full 

exemption for certain forms of natural 

gas. EPA also requested comment on the 

creation of additional exemptions, but 

asked that commenters provide a clear 

supporting rationale for creating such 

exemptions. 

a. Inorganic chemicals - Many 

commenters submitted comments about 

the removal of the full exemption for 

inorganic chemicals. 

EPA originally created the inorganic 

chemical exemption because it believed 

that the hazard potential of many 

inorganics was ‘‘relatively wellestablished’’ (50 FR 9944, 9947, March 

12, 1985) and that hazard information 

alone was sufficient for prioritization 

within inorganic chemical substance 

risk assessments. EPA now intends to 

increase the consideration given to 

exposure, another component of risk, in 

screening chemicals and in setting 

priorities for risk assessment and risk 

management activities. The Agency no 

longer believes that chemical hazard 

information alone provides a sufficient 

basis for prioritization for these 

purposes. As a result, the former basis 

for this exemption is no longer 

applicable. 

i. Why does the Agency need basic 

IUR information on inorganic chemical 

substances? During interagency review 

prior to proposal it was suggested that 

EPA first collect the IUR information in 

§§ 710.52(c)(1), (c)(2), (c)(3), and 710.58 

of the regulatory text (Parts I and II of 

the revised Form U) on inorganic 

substances before collecting the 

processing and use information in 

§ 710.52(c)(4) of the regulatory text (Part 

III of the revised Form U). It was 

thought that partial reporting would 

allow EPA to become generally familiar 

with the production volumes of 

inorganic chemicals, and would permit 

manufacturers of these substances to 

familiarize themselves with the most 

basic IUR requirements before being 

required to comply with the processing 

and use data requirements. Many 

commenters stated that EPA had not 

demonstrated the practical utility of 

collecting basic information on 

inorganic substances. Other commenters 

felt the Agency should collect these data 

and that inorganic chemicals should not 

have had an exemption under IUR. 

EPA uses basic IUR information in a 

wide variety of ways (as described in 

Units II.C. and E.) and expects the basic 

IUR information on inorganic chemicals 

to be used in similar ways. For example, 

EPA used IUR information in the HPV 

Challenge Program (see http://

www.epa.gov/opptintr/chemrtk/

volchall.htm) to identify chemicals 

produced in aggregate national volumes 

of one million pounds or more. The 

HPV Challenge Program has not been 

able to include inorganic chemicals as 

EPA did not have the necessary 

production volume information on the 

inorganic chemicals produced in or 

imported into this country. 

Additionally, the TSCA Interagency 

Testing Committee (ITC) has 

encountered difficulties in its attempts 

to identify inorganic chemicals for 

recommendations to EPA for testing or 

other further evaluations due to the lack 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 873

of even the most basic IUR data for these 

chemicals (Ref. 30). 

ii. Why is EPA phasing in reporting 

for inorganic chemical substances? EPA 

requested comment on completely 

removing the inorganic chemicals 

exemption, requiring reporting of all of 

IURA information, including the 

information described in § 710.52(c)(4) 

of the regulatory text on inorganic 

chemicals manufactured in volumes of 

300,000 lbs. or more at a site. Some 

commenters supported phased-in 

reporting of this information, where 

EPA would maintain a partial 

exemption (i.e., requiring the reporting 

of all of IURA information except the 

information in § 710.52(c)(4)) for the 

first submission period only and would 

require full reporting in subsequent 

submission periods. EPA agrees with 

this approach because it provides new 

submitters with an opportunity to 

become familiar with basic IUR 

reporting, allows EPA to become 

familiar with the current inorganic 

chemical industry, and provides basic 

production information in the first 

submission period. Requiring full 

reporting for inorganic chemicals in 

subsequent submission periods provides 

EPA with the processing and use 

exposure-related information needed to 

continue efforts begun with the first 

reporting year information. 

EPA’s primary use of both the basic 

data collected during the first 

submission period and the additional 

exposure-related data collected during 

subsequent submission periods will be 

to identify priority TSCA chemicals for 

more detailed information gathering, 

risk assessment, and risk management 

in order to develop targeted programs to 

protect human health and the 

environment. Screening chemical risks 

generally requires a combination of both 

hazard and exposure information. The 

absence of exposure-related data for 

inorganic chemicals, beyond even the 

basic production data collected during 

the first submission period under IURA, 

would severely limit the usefulness of 

IURA data for risk screening. See Unit 

III.A.1. for further discussion of 

additional uses of IURA exposurerelated data. 

While some commenters supported 

the phasing-in approach, other 

commenters suggested that EPA review 

the information collected on inorganic 

chemicals under the partial exemption 

and collect additional information on 

these chemicals through a future 

rulemaking. Commenters suggested a 

variety of ways to collect this additional 

information, including specifically 

listing chemicals that would be subject 

to future IUR collections or using PAIR. 

However, EPA’s experience with using 

information from other sources or 

collecting information using PAIR has 

demonstrated that this approach is 

insufficient, as discussed in Unit III.A.3. 

iii. Why doesn’t EPA use already 

available information on inorganic 

chemical substances? Commenters 

stated that the inorganic chemicals data 

that EPA needs to conduct screening 

level risk assessments are already 

available from a variety of sources, 

including the USGS’s annual reports on 

mineral production, health assessment 

documents prepared by the Agency for 

Toxic Substances and Disease Registry, 

studies by OSHA, the TRI compiled by 

EPA, and literature published by trade 

associations. EPA closely examined 

these data sources, and concluded that, 

while useful, these sources are 

inadequate to meet the Agency’s data 

needs for inorganic chemicals. 

Some of the suggested data sources 

pertain to naturally occurring 

substances which are exempted from 

reporting by a provision in IUR that EPA 

has not proposed to change, i.e., 40 CFR 

710.26(a)(3), which is codified as 

§ 710.46(a)(3) for IURA. Many of the 

remaining data sources identified by 

commenters pertain to metallic alloys or 

studies of a single metal species and do 

not include information on the 

multiplicity of pigments, flocculating 

agents, oxidants, photochromic salts, 

flame retardants, catalysts, and other 

inorganic compounds for which data are 

sought through IURA. In some cases, the 

data sources are one-time collections of 

information and therefore would not 

provide current information on the 

inorganic chemical industries. Others, 

although revised from time to time, do 

not identify the chemicals with 

sufficient specificity, do not identify the 

manufacturing site or a technical 

contact, and/or do not provide 

information on the use of the inorganic 

chemical. In sum, the data sources 

identified by commenters and by EPA 

are not sufficient to provide the 

information sought through IURA. EPA 

has consulted with USGS to investigate 

whether the USGS annual survey of 

approximately 80 minerals could be 

amended to better serve as a source for 

use and exposure data that could be 

used in place of IURA for those minerals 

(Ref. 31). EPA plans to identify and 

initiate dialogues with other federal 

agencies about collection activities that 

have the potential for generating 

additional federal paperwork burden 

reductions, particularly related to the 

IURA. The new exemption process 

established in the final rule provides an 

opportunity for EPA to consider 

alternate sources of information for 

individual chemicals. EPA is extremely 

sensitive to the PRA’s directive for 

federal agencies to reduce unnecessary 

burden, and will continue to 

consistently strive to find areas in 

which burden can be decreased to the 

maximum extent practical, as well as 

carefully evaluate new or revised 

information collections to ensure that 

the Agency’s informational needs are 

met with the minimal burden possible. 

Although none of the identified 

alternate sources appear to be sufficient 

to replace IURA, EPA believes that an 

alternate information source could 

provide sufficient information for a 

particular chemical. EPA is also willing 

to work with other agencies to perhaps 

resolve differences in the various 

information collection activities in an 

effort to reduce overall reporting burden 

on industry. 

Additional discussion of the 

applicability of available data sources is 

found in ‘‘Summary of EPA’s Responses 

to Public Comments Submitted in 

Response to Proposed TSCA Inventory 

Update Rule Amendments’’ (64 FR 

46772) (Ref. 18) and in ‘‘Inorganic 

Chemicals: Sources of Information 

Suggested by Commenters to the 

Proposed Inventory Update Rule 

Amendments’’ (Ref. 32). 

b. Partial exemption for petroleum 

process streams. EPA proposed a partial 

exemption from IURA reporting for 

certain chemical substances that the 

Agency is calling ‘‘petroleum process 

streams’’ for purposes of IURA and 

requested comment on duplication of 

reporting under the information 

collections conducted by DOE’s Energy 

Information Administration (EIA) 

through EIA forms EIA 810, EIA 816, 

and EIA 64A. Operators of all operating 

and idle petroleum refineries, blending 

plants, or blending terminals must 

complete form EIA 810 to provide a 

monthly refinery report on their 

operations to DOE. Operators that 

extract liquid hydrocarbons from a 

natural gas stream and/or separate a 

liquid hydrocarbon stream into its 

component products must complete 

form EIA 816 to provide a monthly 

natural gas liquids report to DOE. 

Operators of domestic natural gas 

processing plants must complete form 

EIA 64A to provide an annual report of 

the geographical location and geological 

formation of natural gas liquids 

production to DOE. In the IURA 

proposal, EPA stated its intention to 

work with DOE to identify potential 

duplication and to further investigate 

the potential usefulness of DOE’s 

information collections in fulfilling 

EPA’s statutory obligations under TSCA. 

874 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

One commenter stated that EPA could 

use the DOE data along with other 

supplemental information sources to 

generate the type of petroleum process 

stream information that IURA proposed 

to collect. Several commenters also 

stated that the proposed IURA reporting 

would be duplicative of DOE reporting 

for certain chemicals, particularly fuel 

oil #2 and kerosene, and that EPA 

should therefore fully exempt those 

chemicals from reporting under IURA. 

EPA has investigated the information 

collection conducted by DOE through 

EIA forms EIA 64A, EIA 810, and EIA 

816, and has determined that chemical 

substances are not sufficiently identified 

for EPA’s purposes in the DOE reports. 

For example, many of the chemical 

substances in the DOE reports are 

identified by nomenclature other than 

the CAS nomenclature used by EPA for 

TSCA purposes, are identified in broad 

categories, or are not identified by CAS 

number. Many of the chemical names 

used by DOE are either generic or 

represent groups of chemicals. For 

example, distillate fuel oil, reported on 

EIA Form 810, may refer to several 

chemicals on the TSCA Inventory, such 

as fuel oil #2, fuel oil #4, or fuel oil #6. 

This lack of specific identifier 

information means that EPA and others 

cannot distinguish which information 

collected by DOE is attributable to 

which chemical. More specific 

identification is needed to attribute the 

appropriate hazard and physical and 

chemical properties to the petroleum 

stream. 

The DOE information also lacks 

important exposure components and 

identifiers that are necessary for 

exposure and risk screening activities. 

For example, the DOE information does 

not contain the number of workers 

reasonably likely to be exposed to a 

chemical or the maximum concentration 

of the chemical. In addition, it may be 

difficult to discern from the DOE data if 

a petroleum process stream is used as a 

solvent in a consumer product or as a 

combustible fuel. This is an important 

distinction because the likelihood of 

exposure to a petroleum process stream 

depends on its use. These data are 

needed elements that will fill a vital 

data gap in chemical risk screening. 

Several persons commented that there 

is no need to collect exposure-related 

data for petroleum process stream 

manufacturing operations because 

physical hazards existing at many sites 

currently necessitate extensive safety 

precautions that limit worker exposure. 

Discussed in more detail in Unit II.F.1.b. 

c. Exemption for certain forms of 

natural gas. EPA proposed that six 

natural gas substances be fully exempt 

from reporting under IURA. In addition, 

EPA requested comment on whether 

reporting for the six substances should 

be required in upcoming submission 

periods and whether they were the 

appropriate natural gas substances for 

inclusion in the proposed exemption. 

Commenters expressed support for 

the full exemption of the six natural gas 

streams listed in the proposed IURA. 

These commenters also recommended 

adding fuel oil #2, kerosene, methane, 

ethane, propane, butane, pentane, and 

hexane, and liquefied natural gas to the 

full exemption list. The commenters 

stated that an exemption is warranted 

for these chemicals because: (1) DOE 

already requires annual and monthly 

reports for the chemicals which contain 

the same information requested by EPA; 

(2) the chemicals are similar in chemical 

composition to the six chemicals EPA 

proposed to exempt; (3) their chemical 

structure and identity remain the same 

throughout processing; (4) a similar 

amount of data is available for these 

chemicals as for the six chemicals EPA 

proposed to exempt; and, (5) a similar 

number of TSCA reports are filed for 

these chemicals as for the six chemicals 

EPA proposed to exempt. 

EPA has retained the exemption for 

certain forms of natural gas as proposed. 

Adequate IUR information has been 

collected on the six chemical substances 

to fulfill EPA’s and other IUR 

information users’ current needs. EPA 

will take action to revoke this 

exemption if circumstances warrant in 

the future. 

Liquefied natural gas, which is a form 

of natural gas (CAS No. 8006–61–9), is 

covered under the natural gas 

exemption. EPA did not include ethane, 

methane, propane, butane, other 

paraffinic hydrocarbons, fuel oil #2, or 

kerosene in the list of substances 

included in the natural gas exemption 

because they are not just isolated 

components of natural gas but are also 

chemical substances which can be 

produced from other source materials, 

chemical process streams, feedstocks, or 

reactants. These alkanes have significant 

uses in chemical manufacturing, 

including the production of ammonia 

and methanol from synthesis gas 

derived from methane, thermal cracking 

of ethane/propane mixtures to produce 

ethylene, and vapor-phase oxidation of 

n-butane to produce maleic anhydride. 

At present, there is not a sufficient basis 

to conclude that data on all significant 

uses of these alkanes are adequate. 

EPA did not rely on the data 

contained in the DOE reports discussed 

in Unit III.C.1.b. in its creation of the 

new exemption for certain forms of 

natural gas. While some useful 

information for these chemicals is 

included in the DOE reports, it is 

insufficient for exposure or risk 

screening (see Unit III.C.1.b.). 

Downstream processing and use 

exposure information collected through 

IURA for these chemicals will not 

duplicate information collected by DOE. 

2. Exemption of additional groups of 

chemicals from IURA reporting or from 

the reporting of specific data elements. 

EPA requested comment in the 

proposed rule on the selection of 

chemicals that might be exempted from 

reporting under IURA and on specific 

criteria to distinguish these chemicals 

from those that remain subject to 

reporting. EPA received many industry 

comments in favor of creating a new 

exemption for chemicals that may be 

considered to be ‘‘low priority,’’ but 

commenters did not indicate standard 

criteria for establishing such 

exemptions. However, in response to 

these comments and comments received 

during interagency review, EPA created 

a partial exemption (i.e., an exemption 

from the reporting of information 

required under regulatory text 

§ 710.52(c)(4)) for certain chemicals for 

which the collection of processing and 

use information is currently of ‘‘low 

interest.’’ This new partial exemption is 

intended to improve IURA’s efficiency 

and effectiveness. EPA has established a 

process by which future changes to the 

chemicals included in the partial 

exemption can be made after careful 

examination of the totality of 

information available for the chemical 

substance, including but not limited to 

the considerations provided in 

§ 710.46(b)(2) and discussed in Unit 

II.F.1.d. This partial exemption also 

provides additional benefits in reducing 

the potential reporting burden of IURA 

for certain manufacturers of these 

chemicals. The inclusion of a chemical 

substance under this partial exemption 

does not address the potential risks of 

a chemical. This partial exemption is 

solely intended to provide a tool to 

assist the Agency in better managing the 

collection of processing and use 

information under IURA. See Unit 

II.F.1.d for a discussion of the 

exemption and the process to add or 

remove chemical substances from the 

exemption. 

In addition, commenters suggested 

classes of chemicals for exemption. EPA 

has determined that none of these 

suggested exemptions can be 

implemented at this time, as described 

in the remainder of this section. 

a. HPV chemicals. A number of 

commenters stated that industry is 

already providing EPA with sufficient 

hazard data via the HPV Challenge 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 875

Program (see http://www.epa.gov/

opptintr/chemrtk/volchall.htm), as well 

as exposure data through other 

voluntary programs (e.g., International 

Council of Chemical Associations 

(ICCA) data collections and UEIP). 

Therefore, providing exposure-related 

information on HPV chemicals via IURA 

would be duplicative and unnecessary. 

The Agency recognizes that a variety 

of voluntary and regulatory efforts to 

collect hazard data are underway, such 

as the voluntary HPV Challenge 

Program. However, the scope and 

expected output from the HPV 

Challenge Program differ markedly from 

those anticipated under IURA. The HPV 

Challenge Program centers on providing 

basic hazard data for HPV chemicals, 

most of which will also be IURAreportable chemicals. The IURA focus is 

on gathering exposure-related 

information for moderate and high 

volume chemicals in a wide range of 

industrial operations, involving 

multiple sites and covering 

manufacturing, processing, and use of 

the chemical substances. 

The Agency is unable to limit its 

IURA information collection efforts to 

HPV chemicals alone, for several 

reasons. The Agency could not know 

definitively which chemicals are HPV 

substances in any particular IURA 

reporting cycle as of that reporting year. 

A chemical substance meets the criteria 

for an HPV chemical by meeting a one 

million pound national production 

volume threshold, based upon the 

aggregate production volume in the 

nation (as reported to IUR). Production 

volumes can vary significantly over a 4–

year reporting cycle, and it is not 

uncommon for chemicals to rise above 

or fall below the HPV threshold each 

reporting cycle. For instance, EPA used 

1990 IUR reporting to identify 

approximately 2,800 HPV substances. 

An additional 500 substances which 

were not HPV chemicals in 1990 were 

identified as being HPV via the 1994 

IUR production volume data. The IURA 

collection could be limited to the HPV 

Challenge Program chemicals (i.e., the 

baseline set of chemicals for the 

program, consisting of chemicals that 

were HPV according to 1990 IUR 

information). However, that restricts 

IURA’s ability to supply screening level 

exposure information to only those HPV 

chemicals. This would severely limit 

the usefulness of IURA over time, as the 

universe of chemicals that were HPV in 

1990 will not be the same universe of 

chemicals that are HPV in future years, 

and would compromise the Agency’s 

broader responsibility for risk screening. 

b. Existing Chemicals Program ‘‘low 

concern’’ chemicals. Commenters 

recommended that the chemicals 

previously determined by EPA to be of 

low concern via the Existing Chemicals 

Program be exempt from reporting 

under IURA. However, commenters did 

not provide sufficient criteria that 

would clearly distinguish exempted 

chemicals from others subject to IUR 

reporting. EPA cannot create 

exemptions without a clear basis or 

justification. During the development of 

these amendments, EPA considered 

exempting chemicals previously 

reviewed by the Existing Chemicals 

Program, but was unable to develop 

standard criteria for such an exemption 

(See Ref. 33 and Unit IX.3. of the 

proposal preamble, at 64 FR 46794). 

Under the Existing Chemicals Program, 

no standard criteria were used for 

determining which chemicals were 

lower priority, because in the course of 

the program many different chemicals 

involve unique risk assessment or risk 

management issues. For example, many 

chemicals were analyzed within a 

specific use, and other uses were not 

examined. As an alternative to this 

approach, EPA developed a partial 

exemption for chemicals which are 

determined to be of low current interest 

for purposes of IURA processing and 

use information reporting, based on 

considerations described in Unit 

II.F.1.d., and identified an initial list of 

chemicals currently covered by the 

partial exemption (Ref. 5). 

c. Organization for Economic 

Cooperation and Development (OECD) 

chemicals. Commenters recommended 

that the chemicals for which EPA has a 

minimum set of hazard and exposure 

data, such as OECD’s SIDS chemicals 

that have completed the SIDS process, 

be exempt from reporting under IURA. 

Commenters also suggested that 

chemicals in the International Council 

of Chemical Association (ICCA) 

screening level data collection programs 

be included in this exemption. 

EPA disagrees that data collection 

efforts through the OECD and ICCA 

programs provide sufficient exposure 

information to replace IURA 

information. Data collection efforts 

under the auspices of OECD and ICCA 

concentrate on the development of 

hazard assessments and generally 

provide only a small fraction of the 

exposure-related data called for under 

IURA. A goal of the ICCA Program is to 

process chemical cases through OECD’s 

HPV SIDS Program, which develops 

hazard information for the program 

chemicals. As hazard data do not 

change from year to year, the data 

collection supports a one-time report. 

The IURA will provide current 

exposure-related information for risk 

screenings and preliminary assessments. 

Exposure information, as collected 

under IURA, will vary from reporting 

year to reporting year and therefore 

needs to be collected on a continuing 

basis. While the OECD HPV SIDS 

Program does not specifically disallow 

the collection of exposure information, 

the program does leave such collection 

to the discretion of the sponsor country 

(Ref. 34). Exposure information 

available via SIDS is therefore generally 

not specific to U.S. uses and concerns. 

d. Metals. Various commenters stated 

that either metals as a group, or specific 

metals such as zinc and copper, should 

be granted special consideration for 

IURA reporting. Several commenters 

asserted that providing information on 

maximum concentrations is 

unnecessary for the metals, because they 

will generally have close to 100% 

concentrations when they leave the 

manufacturing site or whenever they are 

present in consumer or commercial 

products. Further, commenters indicate 

that the only exposure potential for 

these substances in commercial or 

consumer products will be dermal (not 

via other routes such as inhalation or 

ingestion). Additionally, a commenter 

stated that workers ‘‘in proximity’’ to or 

handling solid metal articles should not 

be considered to be exposed for 

reporting purposes, because the metal is 

in a form in which neither inhalation 

nor dermal exposure will occur. Other 

commenters believed that any IUR 

reporting on metals is unnecessary 

because ample information on metals 

production and exposure potentials is 

already available from other sources, 

such as the USGS, or because specific 

metals, such as copper and zinc, are 

beneficial to human health and 

therefore should be of no exposure 

concern. 

Metals present some unique issues 

regarding exposure potential, and the 

information that will be collected under 

IURA on metals will do much to 

improve EPA’s and others’ knowledge 

about the uses and exposures associated 

with these chemicals. Not all metalcontaining products are pure metal. For 

example, metal powders used in fine 

arts, metal pastes used in repairs, and 

commercial metallic paints contain 

varying percentages of metals. In 

addition, although some metals in trace 

quantities, such as chromium, are 

essential nutrients to plants and/or 

animals, in greater exposure 

concentrations these same metals can be 

harmful. 

Because metals are ubiquitous and 

can be present in a variety of physical 

forms, different routes of exposure are 

possible. Chronic exposure to solutions 

876 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

containing metals such as nickel may 

result in contact dermatitis. Milling 

metal parts containing antimony and 

beryllium creates dusts which, if 

inhaled, can result in acute chemical 

pneumonitis. Inhalation of fumes 

containing chromium resulted in an 

elevated incidence of bronchial 

carcinoma among workers in the U.S. 

chromate industry before the source of 

the exposure was recognized and 

corrected. Exposure by ingestion is of 

concern for metals that may enter water 

sources following improper disposal of 

used materials, for example. The use of 

cadmium in batteries for portable 

electronic devices, including computers, 

is increasing; long-term exposure to 

cadmium has a potential to cause 

kidney, liver, bone, and blood damage. 

EPA has exempted submitters that 

would otherwise be subject to IUR 

reporting from reporting with respect to 

chemicals that are imported in the form 

of an article (see 40 CFR 710.30(b) and 

§ 710.50(b) of the regulatory text). 

However, submitters that manufacture a 

reportable chemical and incorporate it 

into an article will continue to be 

subject to reporting under the IURA. 

The Agency reviewed a number of 

sources that provide information about 

metals production and characteristics, 

including USGS data specifically noted 

by commenters (Ref. 32). The 

information, although useful for 

depicting global mining and production 

of the major commercial metals, is not 

comparable to the national scale and 

domestic exposures data that will be 

provided under IURA. Further, because 

metals are subject chemicals in many 

EPA programs, including the Great 

Lakes Binational Toxics Strategy; the 

revised drinking water standards; the 

revised emission standards for 

secondary metal refinishers; and the 

Waste Minimization National Plan, 

current information about domestic 

metals production and use will benefit 

many EPA offices and programs. 

As indicated previously, EPA will be 

reconsidering individual chemicals for 

applicability under the new partial 

exemption, and plans to identify and 

initiate dialogues with other federal 

agencies about collection activities that 

have the potential for generating 

additional federal paperwork burden 

reductions, particularly related to the 

IURA. 

e. Other chemical groups. 

Commenters suggested EPA exempt a 

variety of additional groups of 

chemicals from either full or partial 

IURA reporting. These groups included 

fossil fuel combustion byproducts such 

as coal combustion products; fertilizers; 

substances encapsulated in a polymer 

matrix; pesticides; and certain 

chemicals outside the scope of TSCA 

jurisdiction (such as drugs). 

Commenters stated that exposures 

associated with fossil fuel combustion 

byproducts are already well known, 

and, with information currently being 

submitted to EPA and other federal 

organizations such as DOE, well beyond 

the amount needed for ‘‘basic 

screening.’’ Commenters argued that 

reporting on these byproducts under 

IURA would be duplicative (therefore 

unnecessary) and overly burdensome, 

especially because these chemicals are 

considered ‘‘beneficially used in an 

environmentally sound manner’’ by 

EPA’s Office of Solid Waste (OSW). A 

parallel argument was made for 

fertilizers, in that certain commenters 

consider them to be well-characterized 

and generally ‘‘safe.’’ Similarly, a 

commenter believed encapsulated 

substances are of little concern, due to 

low exposure potentials for the 

encapsulated chemicals, as implied by 

the Agency’s treatment of such 

substances under Significant New Use 

Rules (SNURs); the commenter believed 

that, when chemicals are secured within 

a polymer matrix, the SNUR 

requirements no longer apply. 

Commenters also stated that pesticides 

and other chemicals not subject to 

TSCA should be fully exempt from 

reporting. 

Comments specific to these different 

groups of chemicals are addressed 

below. 

i. Fossil fuel combustion byproducts. 

Commenters stated that fossil fuel 

combustion byproducts have been 

sufficiently studied for beneficial reuse 

to justify their full exemption from 

IURA reporting. They asserted that 

EPA’s OSW had adequately reviewed 

data on these substances to allow their 

use as solid waste in situations where 

exposures were possible, such as in the 

case of soil amendments. The 

commenters believe that EPA offices 

such as OPPT and OSW must 

coordinate their efforts related to fossil 

fuel combustion byproducts prior to 

undertaking any actions under TSCA, 

and suggested that continued reporting 

on these chemicals would be 

particularly burdensome. 

EPA disagrees with these comments. 

Review of the recent OSW Report to 

Congress on the subject of fossil fuel 

combustion byproducts (Ref. 35) 

indicates that these products can be 

hazardous to human health and the 

environment when mismanaged. These 

products not only typically contain 

heavy metals such as cadmium, 

chromium, lead, and mercury, but 

leachates from fuel combustion 

byproducts can contain significant 

concentrations of arsenic. Despite these 

concerns, OSW has decided to exempt 

these substances from regulation as 

hazardous waste when they are 

beneficially reused. While OSW was not 

able to identify damage cases or 

significant risks to human health or the 

environment associated with these types 

of beneficial uses based on available 

data, OSW plans to assess new 

information on risks as that information 

becomes available. The IURA will be 

instrumental in providing 

manufacturing, processing, and use data 

for fossil fuel combustion byproducts to 

enable OSW to monitor the potential 

risk associated with these chemical 

substances. Additionally, as with any 

chemical byproduct with a use, EPA in 

general needs information to be able to 

screen these chemicals for potential 

concerns outside of the OSW purview. 

Review of such contemporary data, as 

shared between OPPT and OSW, will 

allow EPA to make well-informed risk 

management decisions by constructing 

realistic screening level exposure 

profiles for these substances. These 

profiles could be adjusted as the 

production dynamics change between 

IURA reporting cycles. EPA believes the 

importance of accurate exposure-related 

data in formulating sound risk 

management decisions for fossil fuel 

combustion byproducts justifies the 

associated reporting burden. 

ii. Fertilizers. Fertilizers that qualify 

for the inorganic exemption have not 

been subject to IUR reporting in the 

past. A number of commenters 

emphasized that, in general, fertilizers 

are chemicals whose risks have already 

have been well-characterized. 

According to the commenters, ample 

recent hazard and exposure data from 

studies conducted by EPA’s OSW 

indicate that fertilizers generally are of 

low toxicity, and some constituents of 

major fertilizer types are ‘‘safe’’ because 

the exposure potentials are low. Further, 

as the commenter pointed out, recent 

SIDS program studies on urea, a 

common fertilizer, described the 

chemical to be ‘‘of low priority’’ for 

further investigation, thereby implying 

that the chemical poses little hazard to 

human health and the environment, and 

that adequate risk information is 

available. Commenters stated that 

because they believe the constituents 

are not harmful to human health or the 

environment, fertilizers should be 

exempt from downstream use and 

exposure reporting under IURA (i.e., a 

partial exemption from IURA reporting). 

Other commenters stated that fertilizers 

should be granted a full exemption from 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 877

IURA reporting, or that EPA should 

exempt certain fertilizers by CAS 

number. One commenter suggested that 

20 substances be included in the 

fertilizer list (see list provided in 

Comment C4b-6 of the comment 

summary document, Ref. 18). 

EPA does not believe the suggested 

IURA exemptions for fertilizers and 

fertilizer constituents are warranted at 

this time. The Agency does not agree 

with industry comments citing a 1999 

EPA OSW risk evaluation on ‘‘nonnutritive’’ components in fertilizers as 

adequate justification for classifying 

fertilizers as ‘‘safe,’’ and therefore 

eligible for exemption. The OSW report 

addresses trace quantities of metal 

contaminants in those fertilizers (i.e., 

the non-nutritive elements), not the 

fertilizers themselves. A review of basic 

hazard identification guides, such as the 

Merck Index, the Condensed Chemical 

Dictionary, and Dangerous Properties of 

Industrial Materials, shows that 

exposure to many fertilizers and 

fertilizer materials, including those 

cited in industry comments such as 

anhydrous ammonia, potassium sulfate, 

and urea, can cause both reversible and 

irreversible adverse health effects 

ranging from acute to chronic. The 

availability of IURA exposure-related 

data will allow for the risk screening of 

chemicals used as fertilizers and 

fertilizer constituents to extend beyond 

environmental effects and aid the 

screening of risks to workers, 

consumers, and the general population. 

The Agency therefore believes it is 

appropriate to require reporting for 

fertilizers under IURA. 

iii. Encapsulated substances. A 

commenter stated that the import 

volumes of IUR reportable components 

contained within compounded 

imported polymers should be exempt 

from IURA reporting. The commenter 

indicated that volumes of these 

encapsulated components are difficult 

to determine. Such components include 

antioxidants, colorants, lubricants, and 

stabilizers that are commonly used 

additives in polymer products. The 

polymers are sometimes manufactured 

by a foreign company and imported into 

the United States. The commenter stated 

that these additives, which are 

encapsulated in a polymer matrix, are 

typically present in the matrix at a few 

weight percent. The commenter’s 

understanding was that when chemicals 

are secured within a polymer matrix, 

the SNUR requirements no longer apply, 

thus their suggestion was for EPA to 

treat such substances similarly under 

IURA. 

The SNUR requirements in 40 CFR 

part 721 do not exempt substances 

encapsulated in a polymer matrix. 

Although chemicals incorporated into a 

polymer matrix are not subject to 

SNURs in certain limited circumstances, 

for example, when an individual SNUR 

specifically states that the SNUR 

requirements do not apply to such 

substances (see, e.g., 40 CFR 

721.8160(a)), such chemicals are not 

otherwise generally exempt from SNUR 

requirements. 

Although EPA appreciates the 

difficulty in ascertaining quantitative 

production information from 

manufacturers outside direct U.S. 

jurisdiction, exempting IUR reportable 

components encapsulated in a polymer 

matrix from IURA is not warranted. Not 

all polymers are inviolable. Additives 

such as colorants and lubricants, which 

can be hazardous to human health or 

the environment, can leach from the 

polymer matrix, resulting in subsequent 

exposures. Also, additives which are 

inherently insoluble in the polymer may 

migrate to the surface of the polymeric 

material and be released over time from 

the polymer. Under IURA, each nonexempted mixture component is 

reportable if imported above the stated 

thresholds. Reasonably ascertainable 

information can be used to estimate 

these import quantities. 

iv. Pesticides. Some commenters 

stated that the Agency should exempt 

pesticide chemicals from reporting 

under the IURA, and also should 

exempt those substances outside the 

scope of TSCA, including drugs and 

cosmetics. 

The original IUR did not require 

reporting for chemicals manufactured 

for non-TSCA purposes. Similarly, in 

IURA, amounts of an otherwise IURreportable substance that are intended at 

the time of manufacture to be used for 

non-TSCA purposes (e.g., as a pesticide, 

as a drug) do not have to be reported. 

For example, if a company were to 

manufacture 300,000 lbs. of an IURreportable substance, 170,000 lbs. of 

which were intended at the time of 

manufacture to be sold as a drug 

precursor, and 130,000 lbs. of which 

were intended at the time of 

manufacture to be used for a TSCA 

purpose, only 130,000 lbs. of the 

substance would have to be reported 

under IUR. The company would not 

have to report the processing and use 

information described in § 710.52(c)(4) 

of the regulatory text for that chemical 

at that plant site, since the company did 

not manufacture a total of at least 

300,000 lbs. of the chemical at the site 

for TSCA purposes. Many substances, 

such as the pesticide active ingredient 

pentachlorophenol, are also used in 

industrial and commercial applications 

regulated under TSCA. In those cases, 

the chemicals will continue to be 

reportable under IURA. 

v. Food additives. Commenters stated 

that low hazard chemicals, such as food 

additives, should be categorically 

excluded from the new reporting 

requirements. The commenter stated 

that food use substances, for example, 

are regulated by the Food and Drug 

Administration (FDA) and must either 

be generally recognized as safe (GRAS), 

the subject of a prior sanction, or the 

subject of a food additive regulation 

promulgated by FDA. 

According to FDA’s Office of 

Premarket Approval (OPA), food use 

substances for FDA’s purposes are those 

that are added directly to food, and 

could inadvertently contact and be 

incorporated into food because of use in 

packaging material or in food 

processing. FDA does not evaluate 

chemicals for environmental effects--

only for human health effects. The 

chemicals subject to FDA rules are not 

inherently low hazard in many cases. 

For example, substances such as 

plasticizers, lubricants, release agents, 

acids (e.g., hydrochloric acid), boiler 

water additives, and solvents (e.g., 

acetone and hexane) are included as 

food use substances. Furthermore, even 

direct (i.e., listed) GRAS chemicals can 

be of concern when used at industrial 

concentrations, such as sulfuric acid. 

Thus, as is true with other chemical 

substances, food additives can present a 

risk to human health or the environment 

depending on use and the resulting 

exposure pathways. EPA does not 

believe a categorical exemption for 

chemicals that may be used as food 

additives is warranted at this time. 

Again, such chemicals are only 

reportable under IURA to the extent that 

they are intended at the time of 

manufacture to be used for TSCA 

purposes. 

3. Thresholds. EPA requested 

comment on the 300,000 lbs. threshold 

for reporting industrial processing and 

use, and consumer and commercial use 

information (required under 

§ 710.52(c)(4) of the regulatory text). 

Commenters generally were supportive 

of having a second, higher reporting 

threshold for this exposure-related 

information. However, one commenter 

stated that the 300,000 lbs. threshold is 

too low, and that it should be set at one 

million pounds to coincide with the 

HPV Challenge Program threshold. 

EPA considered chemicals with 

aggregate, nationwide U.S. production 

and importation volumes of one million 

pounds or more (based on 1990 IUR 

data) for the HPV Challenge Program. 

That is, if one million pounds of a 

878 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

certain chemical were reported for the 

1990 IUR as being produced or imported 

collectively, by manufacturers 

throughout the United States, then that 

chemical was identified as an HPV 

chemical for purposes of the HPV 

Challenge Program. The 300,000 lbs. 

IURA threshold captures at least one 

report for more than 95% of the HPV 

chemicals reported to the 1990 IUR. 

The production volume that defines 

chemicals as HPV should not be 

confused with the 300,000 lbs. per year 

reporting threshold for processing and 

use data reporting in IURA. The 300,000 

lbs. threshold applies to the amount 

manufactured at a single site and is not 

an aggregate, industry-wide production 

number. EPA is implementing the 

300,000 lbs. per year reporting threshold 

for individual IUR submitters because it 

limits the increase in burden associated 

with the new IURA processing and use 

reporting requirements and it limits the 

number of chemicals for which 

exposure-related data will be reported to 

approximately 4,000. This number is 

consistent with the ‘‘several thousand 

chemicals’’ suggested by GAO in its 

1995 report ‘‘EPA Should Focus Its 

Chemical Use Inventory on Suspected 

Harmful Substances’’ (Ref. 36), and 

ensures that exposure-related data will 

be reported for almost all HPV 

chemicals (defined by national aggregate 

production). Increasing the 300,000 lbs. 

threshold to one million lbs. would 

drastically undermine the Agency’s 

collection of processing and use 

exposure-related data. The higher 

threshold would reduce the number of 

chemicals for which this information is 

submitted and eliminate processing and 

use data reporting on many of the HPV 

chemicals. The Agency would be left 

with very little information with which 

to conduct the needed screening- level 

assessments and the resulting 

prioritization would be less meaningful. 

In the proposed IURA, EPA also 

solicited comments on the possibility of 

replacing the chemicals identified using 

the 300,000 lbs. annual production 

volume threshold (by site) with any of 

five other groups of chemicals. Those 

groups include: (1) A set of HPV 

chemicals that submitters identify as 

being produced nationwide in amounts 

of one million lbs. or more; (2) 

chemicals that are currently subject to 

testing under TSCA section 4 (i.e., test 

rules and enforceable consent 

agreements (ECAs)); (3) chemicals 

identified for voluntary testing; (4) 

chemicals designated for testing by the 

ITC; and (5) chemicals listed in the 

Agency’s Master Testing List (the 

current edition is available at http://

www.epa.gov/opptintr/chemtest/

mtl.htm). 

With respect to the possibility of 

limiting the collection of processing and 

use information to HPV chemicals 

identified by submitters, the Agency 

asked for comment on: (1) Whether 

submitters would be able to determine 

which chemicals have exceeded the 

nationally aggregated HPV threshold in 

a given submission period, especially 

given how frequently chemical 

production rises above and falls below 

this threshold from IUR submission 

period to submission period; (2) what 

additional burdens such a 

determination would place on 

submitters; and (3) whether IURA data 

would be less useful if processing and 

use data reporting were limited to HPV 

chemicals. 

Many commenters favored use of the 

set of HPV chemicals in lieu of the 

proposed IURA reporting with the 

300,000 lbs. threshold, yet none directly 

responded to the specific Agency 

questions. Commenters failed to take 

into account the added burden of 

aggregating chemical production to 

determine which substances are HPV 

chemicals. They also offered no 

justification for substituting the 300,000 

lbs. plant site-specific threshold with a 

one million lbs. national aggregate 

threshold, beyond stating that relevant 

information is being provided already 

through other programs. Nor did they 

offer possible solutions to the problem 

of reliably aggregating production 

volumes. 

EPA does not believe that submitters 

will be able to effectively aggregate 

nationwide production volumes. 

Aggregation is especially difficult in 

light of continual, market-driven 

changes in production and many 

submitters’ interest in protecting 

individual plant site production volume 

information as CBI. Additionally, for a 

nationally aggregated one million lbs. 

threshold to be effective, it must be able 

to accommodate the frequency with 

which individual chemicals may rise 

above or fall below the HPV threshold 

criteria of a U.S. aggregate production 

volume of one million lbs. or more per 

year. For example, 17% of the chemicals 

which were HPVs according to data 

submitted under the 1990 IUR were not 

HPVs according to data submitted under 

the 1994 IUR. 

D. Definitions and Clarification 

Requests 

1. Is mining considered 

manufacturing? Commenters asked 

whether mining is considered 

‘‘manufacturing’’ under TSCA. Under 

TSCA, the term ‘‘manufacture’’ includes 

production or importation of a chemical 

substance as well as its manufacture 

(TSCA section 3(7)). Mining, which 

includes extracting metal ores or 

minerals from their natural deposits by 

any means, including secondary 

recovery of metal ore from reuse or 

other storage piles, wastes, or rock 

dumps, or from mill tailings derived 

from the mining, cleaning, or 

concentration of metal ores, is 

production and is considered to be a 

manufacturing activity under TSCA. 

However, chemical substances which 

are naturally occurring and which, 

among other things, are unprocessed or 

processed only by manual, mechanical, 

or gravitational means (see 40 CFR 

710.4(b)(1)) are currently excluded from 

IUR reporting and will continue to be 

excluded under IURA (see 40 CFR 

710.46(a)(3)). For example, rocks, ores, 

and minerals are not IURA-reportable to 

the extent they are manufactured only 

via the means described in 40 CFR 

710.4(b). The § 710.46(a)(3) exclusion is 

a process-specific exclusion rather than 

a chemical- or industry-specific one. 

Therefore, persons who manufacture a 

substance in a manner other than as 

specified in § 710.4(b) are required to 

report under IURA unless they or the 

substance they manufacture are 

otherwise excluded. As a result, many 

mined materials are listed on the TSCA 

Inventory because at least some of the 

time they are produced by other than 

manual, mechanical, or gravitational 

means. 

Section 710.46(a)(3) intentionally 

exempts from IURA reporting any 

chemical substance which is isolated or 

removed from nature, for a commercial 

purpose, by any means listed in 

§ 710.4(b). It also exempts any other 

chemical substance derived or separated 

from the substance originally removed 

from nature, provided such derivation 

involved only the means specified in 

§ 710.4(b). For example, when using 

manual, mechanical, or gravitational 

processes to separate one or more 

substances from a naturally-occurring 

mixture, these isolated component 

substances are also considered 

naturally-occurring and excluded from 

reporting. However, any substance 

manufactured from a naturally 

occurring precursor substance via a 

chemical reaction is not considered 

naturally occurring and, therefore, not 

excluded from reporting under 

§ 710.46(a)(3). 

2. What is the difference between 

‘‘reasonably ascertainable’’ information 

and ‘‘readily obtainable’’ information? 

A number of commenters raised 

concerns about the meaning of ‘‘readily 

obtainable’’ and ‘‘reasonably 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 879

ascertainable,’’ what level of effort is 

required for each, and the difference in 

the level of effort required. Commenters 

also stated that the expectation that 

submitters will provide data on users 

outside their control seems to be an 

unworkable and unrealistic mandate. 

The reporting standard of TSCA section 

8(a)(2) is ‘‘reasonably ascertainable,’’

and commenters stated that this should 

not be construed to include data that are 

not in the possession of the person 

reporting. 

‘‘Known to or reasonably 

ascertainable by’’ is the current standard 

for data collection under which IUR 

operates and is the standard authorized 

by TSCA section 8(a). ‘‘Known to or 

reasonably ascertainable by’’ means all 

information in a person’s possession or 

control, plus all information that a 

reasonable person similarly situated 

might be expected to possess, control, or 

know. The ‘‘known to or reasonably 

ascertainable by’’ standard is applicable 

to the information required under 

§ 710.52(c)(1), (c)(2), and (c)(3) of the 

regulatory text. 

‘‘Readily obtainable’’ is a lesser 

standard EPA is applying to the 

reporting of information concerning the 

processing and use of chemicals subject 

to IURA (§ 710.52(c)(4) of the regulatory 

text). The readily obtainable standard is 

limited to information known by 

management and supervisory employees 

of the submitter, and does not require 

additional effort to collect information 

on processing or use of chemicals by 

others not under the control of the 

submitter. Although the Agency is 

requiring submitters to provide only 

information that it knows, EPA believes 

that in many cases submitters will 

possess some knowledge concerning use 

of chemicals sold by the submitter to 

their customers, even though the 

submitter does not control its 

customers’ sites. For example, when a 

company markets the substances for 

certain end uses. EPA’s experience with 

over 30,000 TSCA section 5 PMNs 

demonstrates that companies generally 

do know the intended ultimate use, as 

well as intervening processing steps, of 

their products. In choosing the readily 

obtainable standard, the Agency is 

lessening the burden on submitters 

compared to the ‘‘known to or 

reasonably ascertainable by’’ standard, 

while recognizing that the submitter is 

supplying data on uses of chemicals that 

are beyond his or her control. The 

standard for reporting information on 

processing and use of chemical 

substances under IURA is the same as 

the standard adopted in the PAIR, 

which was also promulgated under the 

authority of TSCA section 8(a). (See 40 

CFR 712.7) 

E. Confidential Business Information 

The Agency’s intent under these 

regulations is to achieve balance and 

ensure that the submitter only claims as 

confidential that information which is 

legally entitled to confidential 

treatment. EPA believes that these 

amendments will discourage the 

assertion of invalid CBI claims by 

focusing submitter’s attention more 

closely on their decision to make certain 

claims. 

1. General CBI.—a. Reducing the 

amount of CBI claims. EPA solicited 

suggestions from commenters on what 

could be done to the IUR reporting 

process and data elements to reduce CBI 

claims, thereby allowing better public 

access to the data. Some commenters 

suggested that EPA is trying to 

discourage legitimate CBI claims by 

making assertion of such claims overly 

burdensome. Some commenters stated 

that the new data elements that are 

being added by these amendments raise 

significant CBI concerns and that IURA 

can be expected to result in a significant 

increase in the number of legitimate CBI 

claims. 

EPA agrees that submitters will make 

CBI claims for the new data elements 

that are being added by these 

amendments, most likely resulting in a 

greater number of CBI claims overall. 

However, EPA is requiring reporting for 

most of the new data elements in ranges, 

a reporting method EPA believes will 

result in fewer CBI claims compared to 

reporting discrete numbers. 

Additionally, EPA is amending the IUR 

to encourage the assertion of only 

legally valid CBI claims, and to ensure 

that CBI claims are well thought out by 

the submitter. The IURA includes a new 

requirement to provide upfront 

substantiation of CBI claims for site 

identity. This requirement will 

minimize claims by prompting 

submitters to perform an initial 

evaluation of the need for and validity 

of a CBI claim for plant site identity, an 

essential data element. These efforts 

will greatly assist in limiting CBI claims 

to those that are legitimate. 

EPA wishes to clarify that it is not 

attempting to discourage legitimate 

confidentiality claims; rather, the 

Agency intends only to discourage 

inappropriate claims. This allows the 

Agency to protect legitimate CBI while 

also increasing the amount of 

information available for public use. 

EPA has information indicating the 

existence of inappropriate or no longer 

valid CBI claims. For instance, when 

EPA has selectively challenged CBI 

claims in the past, many of these claims 

have been amended by the companies to 

make the information available to the 

public. Additionally, OPPT’s 

administrative record 00125, which 

contains state CBI data reviews, 

published articles, industry letters, and 

other papers discussing CBI issues, 

provides further indication that 

inappropriate or no longer valid CBI 

claims exist. For instance, the Georgia 

Department of Natural Resources 

reported in a 1996 CBI Data Review that 

IUR data identified as confidential was 

available in other non-confidential data 

bases (Ref. 37). The administrative 

record is in the same location as the 

Docket and is available by following the 

procedures identified in Unit I.B.1. 

Some commenters suggested reducing 

the number of data elements that will be 

collected under IURA, perhaps using 

instead a format such as the one used by 

OECD for SIDS chemicals, which 

aggregates information for all 

manufacturers and thus protects 

company-specific information. EPA 

considered alternate reporting formats 

with different data elements, and has 

determined that the reporting of sitespecific information by the individual 

sites is the best way to collect the 

information needed. EPA will continue 

to perform the aggregating function 

when providing the public with 

information that is subject to a sitespecific CBI claim. Collecting only 

national aggregate values would 

drastically reduce the usefulness of the 

information to the Agency, even though 

it may reduce the number of CBI claims. 

The IUR is used to address both national 

needs and local issues. For example, 

IUR production volume information was 

used to identify the national list of High 

Production Volume (HPV) chemicals for 

the Agency’s HPV Challenge Program 

(see http://www.epa.gov/opptintr/

chemrtk/volchall.htm). Moreover, sitespecific IUR information is used to 

secure a better overall understanding of 

activities at individual sites. This 

information is used for site-specific risk 

assessments for the use of federal, state 

and local entities. 

b. Protection of CBI. Some 

commenters expressed concern about 

the Agency’s ability to protect against 

the inappropriate release of CBI and 

stated that, under section 14 of TSCA, 

EPA has a statutory obligation to protect 

information properly claimed as CBI. 

These commenters are concerned about 

past releases of information claimed as 

confidential, and would like to see the 

Agency take steps to guarantee greater 

protection of CBI data. 

EPA agrees that it has a statutory 

obligation to protect information 

880 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

properly claimed CBI and is continually 

involved in exploring ways to better 

protect such information. In this light, 

these amendments reflect the Agency’s 

efforts to assure that information it 

protects qualifies for that protection 

under the established legal standards. 

The new IURA requirements will help 

assure that EPA’s system of information 

protection is limited to valid claims. 

c. Production volume ranges. EPA 

requested comment on the use of 

production volume ranges as a 

mechanism to reduce the number of 

confidentiality claims by allowing 

characterizations of site-specific 

chemical and specific production 

volume information without releasing 

CBI. In general, commenters felt that the 

use of the ranges would not necessarily 

result in reduced CBI claims. 

Commenters cited a few examples 

where production volume would still be 

claimed CBI, including information 

reported in ranges. Other commenters 

suggested using broader ranges. 

Despite these comments, the Agency 

has determined that it is worthwhile to 

require submitters to consider whether 

their production volumes, within ranges 

similar to those used for the original 

TSCA Inventory, warrant protection as 

CBI (EPA made adjustments to the 

original TSCA Inventory ranges by 

making the ranges consistent with the 

second reporting threshold of 300,000 

lbs., as described in Unit II.F.5.d.). EPA 

recognizes that some submitters will 

make CBI claims for both the specific 

and the ranged production volume 

information. However, EPA believes 

that in many cases submitters will allow 

the release of ranged production volume 

information. This belief is supported by 

some industry organizations. For 

example, in a 1993 letter, a company 

suggested the use of the original 

Inventory production volume ranges for 

non-confidential reporting. While the 

company did state that ‘‘conceivably, a 

submitter could be able to justify a CBI 

claim for a range,’’ the conclusion was 

that many companies would be satisfied 

with non-confidential reporting (Ref. 

11). These conclusions are further 

supported by EPA’s experience with the 

original TSCA Inventory, where only 

35% of production volume values 

reported were claimed CBI, compared to 

the typical claim level of 65% for 

production volumes under IUR. 

d. Disclosing customer confidential 

information. A commenter expressed 

concern that, as a producer of chemical 

feedstocks, they might inadvertently 

report customer data and not claim the 

data as CBI, while their customer 

reports the same data and does claim 

the data as CBI. 

EPA does not believe that this will be 

a significant issue. The downstream 

processing and use information that 

some submitters will be required to 

provide under IURA is not tied to 

customer identities. Submitters will not 

report where or who their customers are 

or how much their individual customers 

produce. In addition, CBI claims can be 

made as necessary for any information 

provided on Form U. 

2. Upfront substantiation.—a. 

Authority for substantiation. A 

commenter stated that the plant site 

identity substantiation requirement is 

not authorized under TSCA. Another 

commenter felt that requiring upfront 

substantiation is overly burdensome and 

an arbitrary exercise of authority. The 

commenter stated that substantiation 

should only be required if and when a 

request for public disclosure is made, 

and substantial and reasonable need are 

demonstrated. 

Under TSCA section 14(c), ‘‘a 

[confidential] designation under this 

paragraph shall be made in writing and 

in such manner as the Administrator 

may prescribe.’’ EPA is continuing to 

require that those reporting under IURA 

substantiate their chemical identity CBI 

claims, and is requiring under these 

amendments that submitters also 

substantiate any plant site identity CBI 

claims. Section 710.58 of the regulatory 

text requires submitters to substantiate 

these claims submitted under IUR by 

providing answers to specified 

questions. EPA has long required 

upfront substantiation for specified CBI 

claims under the authority specified in 

TSCA (see, e.g., 40 CFR 710.38(c) of the 

current regulatory text) and will 

continue to require upfront 

substantiation where appropriate. 

The Agency is adding upfront 

substantiation requirements for plant 

site identity information because EPA 

has observed that, on occasion, plant 

site information has been claimed as 

confidential even though, for example, 

it was revealed in filings required under 

sections 311, 312, and 313 of the 

Emergency Planning and Community 

Right-to-Know Act (EPCRA), 42 U.S.C. 

sections 11021 to 11023. EPA believes 

that many of these CBI claims are 

inappropriate and that the new 

substantiation requirement will reduce 

the occurrence of inappropriate claims. 

A decrease in the number of CBI claims 

under the new substantiation 

requirement would facilitate EPA’s 

ability to make current plant site 

information available to other Federal 

agencies and the public because more 

information submitted under IUR could 

be released publicly. 

Upfront substantiation of CBI claims 

imposes some additional burden, 

although this burden is not substantial. 

EPA’s economic analysis for this rule 

estimates 0.2 to 0.3 hour per plant site 

reporting under IURA for the 

incremental costs of reporting all 

elements of plant site identity 

information. The burden of upfront 

substantiation for plant site identity CBI 

claims is included in this estimate. 

b. Alternate substantiation questions. 

One commenter suggested a simplified 

set of substantiation questions, 

consisting of two questions: (1) Are the 

specified data confidential? and, (2) In 

as much detail as possible, explain why 

this information should be given CBI 

protection. 

EPA believes that requiring responses 

to the list of substantiation questions in 

§ 710.58 of the regulatory text is 

necessary to ensure that information 

submitted for confidential protection 

qualifies for that protection. The 

commenter’s proposed questions, while 

providing the opportunity for a 

submitter to express its business reasons 

and preferences regarding the 

information, do not provide all of the 

necessary information to definitively 

evaluate the eligibility of the 

information for confidential treatment. 

3. Reassertion. EPA received a 

number of comments regarding the 

proposed new CBI reassertion 

provisions. All of these comments were 

opposed to the proposed new 

requirement. Some comments expressed 

the position that reassertion is overly 

burdensome and even punitive, 

requiring submitters to retrace old steps 

by answering all the original 

substantiation questions anew. 

Commenters were concerned that 

reassertion could possibly require the 

retention of voluminous old records. 

Others felt the proposed standards 

would violate the Agency’s obligation 

under TSCA to protect confidential 

information and that EPA would exceed 

its authority if it required the reassertion 

of CBI claims. 

EPA has considered these industry 

comments, and weighed the concerns 

expressed against the public’s need for 

access to information on chemicals in 

commerce in the United States. While 

the Agency believes the requirement to 

reassert old claims of CBI is justified as 

a practical measure to ensure that 

information withheld meets the legal 

criteria and that the expressions of 

concern relating to burden associated 

with reassertion, appear to be the result 

of a misunderstanding of the practical 

aspects of the proposed reassertion 

requirement, the Agency is not 

finalizing the proposed reassertion 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 881

requirement. EPA has made this 

decision in an effort to reduce the 

overall burden of these amendments. 

F. Administrative Comments 

1. Frequency of reporting. Several 

commenters stated that one-time 

reporting of IURA information would be 

more appropriate in most cases for the 

intended purposes expressed by EPA. In 

general, commenters stated that EPA 

could use tools such as PAIR to identify 

changes in a particular chemical’s 

exposure or use profile at the time the 

Agency decides to do a risk analysis for 

that chemical (see Unit III.A.3.). A few 

commenters stated that there is 

insufficient change in the chemical 

industry to warrant recurring reporting 

of IURA information, especially for 

higher volume chemicals. 

EPA’s experience with past IUR 

reporting demonstrates that the 

chemical industry is dynamic, with a 

30% change in the number of chemicals 

reported from one submission period to 

the next. The specific chemicals that are 

reported or not reported in any single 

submission period change at a variety of 

production volumes; this change is by 

no means limited to lower production 

volume chemicals. 

Although a chemical’s hazards may be 

fully characterized, EPA needs up-todate exposure information to stay 

current with developments and 

adequately screen chemicals for 

possible risks to human health and the 

environment. While the toxicity of a 

chemical does not change (although 

new information can modify the 

assessment or identify new concerns), a 

chemical’s exposure profile can vary 

greatly over time. Human and/or 

environmental exposures to the 

substance can at one time be minor, but 

as uses change from industrial 

applications to consumer uses, or as 

production volumes increase, exposures 

also tend to increase. Because exposures 

and uses can and do change over time 

as technologies develop or innovations 

arise, updated exposure information is 

needed to maintain an adequate 

understanding of current exposures. 

EPA did consider one-time reporting for 

IURA processing and use data, but the 

information would quickly become out 

of date. 

A primary goal of IURA is to provide 

a data base of exposure-related 

information which can be used for 

screening level purposes to identify 

chemicals for further assessment, as 

well as chemicals of lesser concern (see 

Unit III.A.1.). EPA intends to use other 

data sources and collection tools, as 

appropriate, once a chemical has been 

identified as a candidate for further 

assessment. 

2. Calendar year reporting. One 

commenter stated that the requirement 

to report data on a calendar year basis 

instead of a company fiscal year basis 

would increase systems development 

needs for companies who report their 

manufacturing volume on a fiscal year 

versus a calendar year (by creating the 

need for a second tracking system), 

while adding no additional value or 

accuracy in the reporting of 

manufacturing data. This commenter 

pointed out that because the most that 

companies’ fiscal years can differ from 

a calendar year is 6 months and IUR 

reporting occurs every 4 years (instead 

of every year), there can be little 

difference in the data with a maximum 

6–month time frame shift. Other 

commenters supported the change to a 

calendar year basis, supporting the idea 

of having a consistent time frame to 

better enable linkages with other data 

bases. 

EPA has retained the calendar year 

reporting cycle as proposed. By moving 

the collection to a calendar year basis, 

the IURA data collection becomes more 

compatible with other data bases such 

as the TRI. This compatibility increases 

the usefulness of the IURA collection by 

allowing IURA data to be combined 

with data from other collections. 

Generally, companies should be 

sufficiently familiar with their 

production that this provision should 

not present special challenges that are 

unaccounted for in the burden estimates 

provided by survey respondents, as 

described in the economic analysis. 

G. Economic Impact Estimates 

Commenters raised a number of 

concerns about the economic analysis. 

In response, EPA has made a number of 

changes to make the analysis a more 

readable document and to incorporate 

changes made to the final IURA 

requirements. 

1. General burden comments. 

Commenters raised a variety of concerns 

about the size of the burden associated 

with the amendments, and EPA’s 

estimates of that burden. In general, 

commenters felt that the Agency’s 

burden estimates were too low. 

However, few commenters provided 

evidence as to why they felt EPA 

underestimated the burden, and none 

provided any specific analytical basis 

for amending the estimates. Some 

commenters claimed that the revised 

form represents a 5-, 10-, or 30–fold 

increase in burden, at least partly based 

upon the fact that the original Form U 

was only 1 page and the sample revised 

Form U provided in the proposed rule 

was 3 pages. 

In response to these comments, EPA 

reviewed the burden analysis and, 

although the estimated burden was 

adjusted, determined that the comments 

do not warrant modifications to the 

Agency’s general approach to the 

analysis. EPA based much of the burden 

analysis on a survey of 78 industry 

respondents (Ref. 7). In addition, EPA 

considered the burden associated with 

such programs as the UEIP (described in 

Unit III.A.1.), a voluntary project in 

which EPA collected information 

similar in some ways to IURA 

information. UEIP respondents provided 

estimates of the amount of time they 

used to complete the survey forms (Ref. 

7). However, EPA did reassess the 

results of the burden survey and did 

make some changes to the analysis. The 

burden from the analysis associated 

with the proposed rule was $36 to $51 

million in the first year, and $27 million 

to $41 million in future reporting years. 

Changes in the rule and methodology 

raised estimated costs of the final rule 

to between $72 and $87 million in the 

first reporting cycle, and $64 to $77 

million in future reporting cycles. These 

changes are primarily due to revising 

the analysis from the survey data, 

revising the analysis to remove the 

reassertion burden, updating costs to 

year 2000 dollars, and updating the 

number of report submissions to 

incorporate the 1998 IUR data 

collection. These changes are discussed 

further in ‘‘Revised Economic Analysis 

for the Amended Inventory Update 

Rule’’ (Ref. 7). 

a. Burden over time. Commenters 

raised concerns about specific burden 

issues. Several commenters felt that 

burden associated with IURA will not 

decrease over time because of the 4–year 

time lapse between submission periods. 

Those commenters believe that the 4–

year period between submission periods 

will result in changes to product lines 

and personnel such that a complete 

reintroduction to IUR reporting will be 

necessary in each reporting cycle. EPA 

disagrees, and expects rule 

familiarization to require the most effort 

in the first year of reporting. EPA 

believes that there will be some 

similarity in the information reported 

from one submission period to the next, 

especially for Parts I and II of the 

revised Form U. Subsequent reporting 

will be facilitated by the site’s 

maintenance of its previous submission 

period’s records. 

b. Characterization of burden 

reduction. Commenters asserted that the 

economic analysis for the proposed rule 

was misleading in its characterization of 

882 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

the actions that constitute burden 

reduction and cost savings. Specifically, 

commenters referred to EPA’s claim of 

a burden reduction and cost savings 

associated with the 300,000 lbs. 

threshold for reporting of Form U, Part 

III information on industrial processing 

and use, and consumer and commercial 

use. EPA simply meant that providing a 

partial exemption for chemicals below 

the 300,000 lbs. threshold is a 

concession to the burden that the rule 

imposes on reporting sites, and that the 

Agency has no other basis for this 

exemption other than to mitigate the 

increase in burden. EPA presented a 

similar discussion comparing options 

considered under the rule for other 

partial reporting exemptions such as the 

petroleum streams exemption. These 

discussions are put into the appropriate 

context in the economic analysis. A 

commenter also took issue with the fact 

that EPA asserts that reporting 

processing and use information on the 

top 10 NAICS codes will reduce costs 

(versus reporting on an unlimited 

number of NAICS codes), given that 

identifying these top 10 could take 

considerable effort. EPA continues to 

believe that reporting only the top 10 

NAICS codes will be less burdensome 

than reporting all NAICS codes 

associated with industrial processing or 

use operations. 

2. Cost comments. Two commenters 

asserted that compliance costs for 

chemicals manufactured in amounts 

below the 25,000 lbs. threshold are not 

zero and that, as production volume for 

a chemical approaches the threshold, 

tracking costs will accrue to determine 

if production will cross the threshold. 

Compliance determination (the act of 

determining the need to comply with a 

regulation) occurs on a per-site basis. 

This means that all sites that report 

under IURA are assumed to incur the 

same average cost for determining 

compliance, regardless of the number of 

chemicals reported. Some small number 

of firms that are not required to report 

may incur some negligible costs in this 

regard, but EPA believes the costs to be 

relatively small given that it is standard 

business practice for a company to be 

aware of the volumes it produces. The 

existence of voluntary submitters does 

not imply that below-threshold 

compliance costs are non-zero; it simply 

indicates that some firms choose to 

respond to IUR when reporting is not 

required. 

Another commenter determined that 

member companies in its organization 

would experience no savings from 

raising the threshold from 10,000 lbs. to 

25,000 lbs. as no reports are eliminated. 

In 1994, EPA received approximately 

3,800 reports for chemicals produced in 

quantities between 10,000 and 25,000 

lbs. As a result, the Agency anticipates 

that a significant number of reports will 

be eliminated by raising the reporting 

threshold. 

3. Benefits comments. Commenters 

stated that EPA has overestimated the 

benefits of this rule and should quantify 

the benefits. However, given that IURA 

is an information rule and its benefits 

are therefore indirect, it is currently not 

possible to quantify the benefits of the 

rule. Only by collecting the information 

required under the IURA can EPA begin 

to assess thoroughly the risks from a 

portion of the more than 76,000 

chemicals in commerce. The actions 

that result from EPA review of the IURA 

data will have direct health and 

environmental benefits, benefits that 

typically can be quantified. Commenters 

offered no alternate assessment, 

quantitative or otherwise, of the benefits 

from IURA. In the absence of quantified 

benefit figures, it is impossible to make 

simple comparisons to estimates of 

reporting costs. Thus, EPA must balance 

the needs of the Agency for data with 

which to address important 

environmental and health risks, with 

the burdens of obtaining such data. In 

doing so, the uses of and need for the 

data are carefully addressed both within 

the Agency, and during interagency 

review. EPA has made every attempt to 

collect only the information necessary 

to meet Agency goals for obtaining 

screening level exposure-related 

information. 

4. Small business impact comments. 

Several commenters argued that EPA’s 

analysis of the impacts of IURA on 

small businesses is insufficient to meet 

the requirements of the Regulatory 

Flexibility Act (RFA), as amended by 

the Small Business Regulatory 

Enforcement Fairness Act (SBREFA) of 

1996. EPA’s analysis of small business 

impacts fully complies with the RFA, as 

amended. For rules subject to the RFA, 

the Agency is required to undertake 

specific actions (such as preparing an 

initial regulatory flexibility analysis and 

convening a small business advocacy 

review panel) unless it certifies that the 

rule will not have a significant impact 

on a substantial number of small 

entities. EPA prepared a thorough small 

entity analysis that meets the 

requirements of the RFA. The analysis 

for the final rule can be found in the 

‘‘Revised Economic Analysis for the 

Amended Inventory Update Rule’’ (Ref. 

7). For both the proposed and final 

rules, EPA certified that there will not 

be a significant impact on a substantial 

number of small entities. A summary of 

the analysis and the certification can be 

found in Unit V.B. 

5. Non-regulatory alternatives. 

Commenters also stated that EPA did 

not identify any non-regulatory 

alternatives and failed to assess the 

relative costs and benefits of an 

alternative approach. In the economic 

analysis for the proposed rule, the 

Agency did not specifically identify 

non-regulatory alternatives to the 

reporting requirements. However, the 

Agency did consider non-regulatory 

alternatives and has added a discussion 

to the economic analysis. 

The Agency primarily considered two 

non-regulatory alternatives. First, the 

Agency considered using publicly 

available information, as discussed in 

Unit III.A.3. The Agency found that the 

information to be collected through 

IURA was not publicly available and 

therefore this was not a viable option. 

Second, the Agency considered a 

voluntary approach to collecting this 

information, similar to the UEIP 

collection discussed in Unit III.A.1. 

However, information collected through 

a voluntary program may lack 

consistency, may not be sufficiently 

comprehensive, or may not occur on a 

recurring basis, and therefore would not 

fully serve the purposes of IURA 

information. Therefore, a voluntary 

approach was not a viable option. 

IV. Materials in the Rulemaking Record 

The public version of the official 

record for this rulemaking has been 

established as described in Unit I.B.1. 

under docket ID number OPPT–2002–

0054. This record includes the 

documents located in the docket as well 

as the documents that are referenced in 

those documents. The following is a 

listing of the documents that are 

specifically referenced in this final rule. 

These documents, and the documents 

referenced therein, are also included in 

the public version of the official record. 

Please note that some referenced 

documents are already publicly 

available and this list includes the 

relevant location information. 

1. U.S. EPA, ‘‘Reducing Risk: Setting 

Priorities and Strategies for 

Environmental Protection,’’ Science 

Advisory Board, (SAB-EC-90-021), 1990. 

2. National Academy of Public 

Administration, ‘‘Setting Priorities, 

Getting Results - A New Direction for 

EPA,’’ 1995. 

3. Chemical Manufacturers 

Association, Synthetic Organic 

Chemical Manufacturers Association, 

U.S. EPA, Chemical Specialties 

Manufacturing Association, American 

Petroleum Institute, ‘‘Round 3 of the 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 883

UEIP (Use and Exposure Information 

Project),’’ June 3, 1996. 

4. American Petroleum Institute, 

‘‘Petroleum Process Stream Terms 

Included in the Chemical Substances 

Inventory Under the Toxic Substances 

Control Act (TSCA),’’ Health and Safety 

Regulation Committee Task Force on 

Toxic Substances Control, February 

1985. 

5. USEPA, ‘‘Methodology Used for the 

Initial Selection of Chemicals for the 

Inventory Update Rule Amendments 

(IURA) ‘Low Current Interest’ Partial 

Reporting Exemption,’’ OPPT, July 24, 

2002. 

6. USEPA, ‘‘EPA Needs ExposureRelated Data: A Discussion of the 

Justification for Collecting ExposureRelated Data Through the IUR 

Amendments,’’ OPPT/EETD/EPAB, 

1998. 

7. USEPA, ‘‘Economic Analysis for 

the Amended Inventory Update Final 

Rule,’’ OPPT, August 2002. 

8. USEPA, ‘‘Incremental Cost 

Estimates for IURA: Interagency Review 

Comparison and Five Year Reporting 

Cycle,’’ OPPT/EETD/EPAB, July 17, 

2002. 

9. USEPA, ‘‘Draft Instructions Manual 

for the 2006 Inventory Update Rule 

Reporting,’’ OPPT, August 2002. 

10. USEPA, ‘‘Inventory Update Rule 

(IUR) Technical Support Document: 

Evaluation of Likelihood of Confidential 

Business Information Claims for 

Production Volume Information,’’

OPPT, August 26, 1996. 

11. Letter from Mark N. Duvall, Union 

Carbide, to EPA, ‘‘Additional Comments 

of Union Carbide Corporation on EPA’s 

Preliminary Actions to Reform TSCA 

Confidential Business Information, 

Docket No. OPPTS–00125,’’ August 31, 

1993. 

12. Letter from Stephen A. Newell, 

Occupational Safety and Health 

Administration, to Wardner G. 

Penberthy, EPA, October 15, 1996. 

13. Letter from Paul A. Schulte, Ph.D., 

National Institute for Occupational 

Safety and Health, to Wardner G. 

Penberthy, EPA, October 8, 1996. 

14. USEPA, ‘‘Inventory Update Rule 

(IUR) Amendment Technical Support 

Document: Exposure-Related Data 

Useful for Chemical Risk Screening,’’

Volumes 1 and 2, OPPT, July 19, 1996. 

15. U.S. Census Bureau, North 

American Industrial Classification 

System (NAICS), http://

www.census.gov/epcd/www/

naics.html, 1999. 

16. USEPA, ‘‘Preliminary Assessment 

Information Rule (PAIR) Database, 

Manufacturing Process Type/Release 

Analysis and Number of Workers/

Production Quantity Analysis,’’ OPPT, 

September 26, 1996. 

17. Standard Consumer Safety 

Inspection ASTM F963-96A (sec. 3.1–

3.3). 

18. USEPA, ‘‘Summary of EPA’s 

Responses to Public Comments 

Submitted in Response to Proposed 

TSCA Inventory Update Rule 

Amendments (64 FR 46772),’’ OPPT/

EETD, September 6, 2002. 

19. USEPA, ‘‘IURA Data Use Plan,’’

OPPT/EETD, August 23, 2002. 

20. USEPA, ‘‘A SAB Report: 

Improving the Use Cluster Scoring 

System, Recommendations for the Use 

Cluster Scoring System Prepared by the 

Environmental Engineering 

Committee,’’ Science Advisory Board, 

SAB-EEC-95-017, September 1995. Also 

available at www.epa.gov/sab/pdf/

eec95017.pdf. 

21. Letter from Michael A. Babich, 

U.S. Consumer Product Safety 

Commission, to Wardner G. Penberthy, 

EPA, June 24, 1996. 

22. Letter from Robert Franklin, U.S. 

Consumer Product Safety Commission, 

to EPA, December 23, 1999. 

23. Letter from Paul A. Schulte, Ph.D., 

National Institute for Occupational 

Safety & Health, to EPA, December 21, 

1999. 

24. General Accounting Office, ‘‘Toxic 

Chemicals: Long-Term Coordinated 

Strategy Needed to Measure Exposures 

in Humans,’’ GAO/HEHS-00-80, May 2, 

2000. 

25. Letter from Linda Greer, Ph.D., 

Natural Resources Defense Council, to 

Carol Browner, EPA, February 12, 1999. 

26. USEPA, ‘‘Economic Analysis of 

Proposed Amendments to the TSCA 

Section 8 Inventory Update Rule,’’

OPPT/EETD/EPAB, March 1, 1999. 

27. USEPA, ‘‘A Review of Existing 

Exposure-Related Data Sources and 

Approaches to Screening Chemicals: A 

Response to CMA,’’ OPPT, March 1999. 

28. European Commission, 

‘‘Technical Guidance Document in 

Support of Commission Directive 93/67/

EEC on Risk Assessment for New 

Notified Substances and Commission 

Regulation (EC) No 1488/94 on Risk 

Assessment for Existing Substances; 

Part III.’’

29. USEPA, ‘‘‘Inventory Update Rule 

(IUR) Technical Support Document: 

Selection of Consumer and Commercial 

End-Use Categories,’’ OPPT, 1996. 

30. Letter from the TSCA Interagency 

Testing Committee providing a response 

to an Interagency proposed rule review 

question, undated. 

31. Letter from John DeYoung, Chief 

Scientist, U.S. Geological Survey, to 

Mary Ellen Weber, EPA, July 25, 2002. 

32. USEPA, ‘‘Inorganic Chemicals: 

Sources of Information Suggested by 

Commenters to the Proposed Inventory 

Update Rule Amendments,’’ OPPT, June 

2000. 

33. Memorandum from Sandy 

Zavolta, U.S. EPA, to Heidi King, Office 

of Management and Budget, May 21, 

1999. 

34. OECD, ‘‘Guidance for Collection 

and Transmission of Exposure 

Information for SIDS Initial 

Assessment,’’ OECD SIDS Manual 

(Third Revision), Section 2.5, July 1997, 

available at http://www.epa.gov/

opptintr/sids/sidsman.htm. 

35. USEPA, ‘‘Report to Congress: 

Wastes from the Combustion of Fossil 

Fuels (EPA Docket #F–2000–FF2F–

FFFFF) Public Comment Summary and 

Response Document,’’ OSW, April 25, 

2000, available at http://www.epa.gov/

epaoswer/other/fossil/ffc-resp.pdf. 

36. General Accounting Office, ‘‘EPA 

Should Focus Its Chemical Use 

Inventory on Suspected Harmful 

Substances,’’ GAO/RCED-95-165, July 7, 

1995. 

37. Confidential Business Information 

Data Review, Georgia Department of 

Natural Resources, Docket entry 00125 

B2a-010 filed June 19, 1996, page 4. 

V. Statute and Executive Order Reviews 

A. Executive Order 12866 

Under Executive Order 12866, 

entitled Regulatory Planning and 

Review (58 FR 51735, October 4, 1993), 

the Office of Management and Budget 

(OMB) has determined that this is a 

‘‘significant regulatory action’’ under 

section 3(f) of the Executive Order, 

because it raises ‘‘novel legal or policy 

issues arising out of legal mandates’’

relating to information collection. This 

action was therefore submitted to OMB 

for review under this Executive Order, 

and any comments or changes made 

during that review have been 

documented in the public record. 

In addition, EPA has prepared an 

economic analysis of the potential 

impacts of this action, which is 

contained in a document entitled 

Economic Analysis for the Amended 

Inventory Update Rule (Ref. 7). The 

Agency, in promulgating this rule, is 

required under TSCA to consider the 

potential costs and benefits associated 

with IURA. The analysis was therefore 

used by the decision-makers to help in 

the selection of the final rule 

requirements presented in this 

document. This document is available 

as a part of the public version of the 

official record for this action and is 

briefly summarized here. 

EPA estimates that these amendments 

will cost between $72 and $87 million 

in the first reporting cycle, and $64 to 

884 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

$77 million in future reporting cycles, 

resulting in an annualized cost of $17 to 

$21 million over the next 20 years at a 

3% discount rate, and $19 to $22 

million at a 7% discount rate. 

Under these amendments, 

approximately 8,900 chemicals will be 

subject to reporting, and the Agency 

expects that it will receive 

approximately 26,800 submissions 

during the first submission period. In 

the first submission period, 

approximately 9,800 of those 

submissions (providing information on 

about 4,000 chemicals) will be full 

reports which include information 

found in Part III of revised reporting 

Form U. The remainder will report only 

company, site and chemical 

identification and manufacturing 

information (Parts I and II of revised 

Form U). In future submission periods 

with the addition of full reporting for 

inorganic chemicals, EPA expects to 

receive over 12,300 full forms, covering 

4,600 chemicals. In order to keep the 

reporting burden as low as possible, 

EPA is requiring that certain 

information be reported in ranges, that 

only the top 10 NAICS codes be 

accounted for when reporting industrial 

processing and use information, and 

that only readily obtainable information 

in Part III of revised Form U be reported. 

EPA analyzed the effects of a number 

of different alternatives for the rule, 

including variations in exemptions, 

different thresholds for both partial- 

(i.e., Parts I and II of revised Form U) 

and full-form (i.e., all parts of revised 

Form U) reporting, and various 

frequencies of collection. These options 

are explored further in the Economic 

Analysis (Ref. 6). 

EPA considered continuing the 

existing full exemption from IUR 

reporting for inorganic chemicals and 

adding a full exemption for site-limited 

petroleum streams. EPA examined the 

effects of keeping the partial-form 

threshold at 10,000 lbs. and considered 

full-form thresholds of 100,000, 

300,000, 500,000, and one million lbs., 

as well as a phased-in 100,000/500,000 

full-form threshold. EPA also 

considered changes in the reporting 

cycle, such as a one-time collection, and 

a 2–year cycle. 

EPA believes that this final rule 

represents an appropriate balance 

between the burden placed on industry 

to provide information and the Agency’s 

need for that information to fill its 

statutory obligations and fulfill its 

mission under TSCA and, as part of that 

mission, to provide information needed 

by other agencies (OSHA, NIOSH, 

CPSC, etc.). 

The costs of these amendments will 

be borne by two groups: the chemical 

industry and EPA. Industry costs are 

associated with complying with the 

regulation, while EPA costs are 

associated with administering the 

regulation and maintaining the collected 

data. In this rulemaking effort, EPA has 

made every attempt to balance data 

needs with collection costs and burden. 

Wherever possible, EPA has used 

exemptions or partial exemptions to 

reduce the number of reports that would 

potentially be filed by industry. EPA has 

provided a second threshold for 

reporting use information required in 

Part III of revised Form U, reducing the 

per report burden for submitters. 

Recognizing that this information will 

be used for screening level purposes, 

EPA has reduced the specificity of the 

information that will be required in 

three ways: (1) By requiring the 

reporting of only readily obtainable 

information for the processing and use 

exposure-related data; (2) by requiring 

that submitters report much of the 

information in ranges, reducing the 

need to generate specific estimates; and, 

(3) by requiring processing and use 

exposure-related information on only 

the top 10 uses/NAICS codes/IFCs, as 

determined by percent of the chemical’s 

volume. These steps limit the amount of 

information required, reducing the time 

and effort spent by the chemical 

industry in complying with the 

amendments. 

EPA assumes that the burden 

associated with reporting under IURA 

will decrease over time as industry’s 

familiarity with the reporting rule 

increases and to the extent that the 

information being reported remains 

somewhat constant from one 

submission period to the next. Projected 

costs to EPA are relatively small and are 

estimated to be $576,000 in the first 

reporting year, and $270,000 in 

subsequent reporting years. 

Substantial changes in the economic 

analysis have occurred since the 

economic analysis produced for the 

proposed rule, which is summarized in 

Unit XI. of the proposed rule (at 64 FR 

46799). The economic analysis was 

revised primarily due to changes in the 

final rule and changes to the cost 

methodology that more fully reflect 

potential industry burden. The revised 

economic analysis in support of this 

final rule can be found in the public 

version of the official record for this 

rulemaking (Ref. 6). 

Changes made since the proposal due 

to public comments or interagency 

review include deleting the average 

concentration data element, phasing-in 

full reporting for inorganic chemicals, 

adding a partial exemption for specific 

chemical substances for which the 

Agency has determined that the IURA 

processing and use information is of low 

current interest, and deleting the 

proposed CBI reassertion requirement. 

Changes made to the cost methodology 

include increasing burden estimates for 

reporting processing and use data. The 

increase in burden estimate was 

initiated in response to industry 

comment, and stemmed from 

differences in the survey instrument 

used to estimate costs of IURA in 1996, 

and the sample Form U in 1999. 

Estimates for reporting processing and 

use data were revised upward after 

reviewing public comments and the 

survey data. Differences between the 

survey instrument and the proposed 

Form U required EPA to aggregate 

certain responses. After reading the 

comments, EPA is using more 

conservative assumptions in this 

process. Therefore, it is more likely that 

EPA cost estimates overestimate, rather 

than underestimate, actual costs. 

B. Paperwork Reduction Act 

The OMB has approved the 

information collection requirements 

contained in this rule under the 

provisions of the Paperwork Reduction 

Act (PRA), 44 U.S.C. 3501 et seq., and 

has assigned OMB control number 

2070–0162. In accordance with the 

procedures at 5 CFR 1320.11, EPA 

submitted an Information Collection 

Request (ICR) document to OMB in 1999 

(identified as EPA ICR No. 1884.02), 

which is also included in the public 

docket that is described in Unit I.B.1. 

The information that will be reported 

under IURA will better enable EPA to 

screen thousands of chemical 

substances for potential risk. Risk 

screening is necessary in order to 

conserve limited Agency and industry 

resources by focusing risk assessment 

work on chemical substances for which 

some level of potential risk has been 

indicated. The new information that 

will be reported under this rule is 

critical to the risk screening process and 

is unavailable through other sources. 

Responses to this collection of 

information will be mandatory, 

pursuant to TSCA section 8(a), 15 U.S.C. 

2607(a). The regulations codifying the 

reporting requirements appear at 40 CFR 

part 710. CBI claims may be made for 

all or part of the information that will 

be reported under IURA. This action 

includes new substantiation procedures 

for CBI claims regarding plant site 

identity (See § 710.58(d) in the 

regulatory text). 

As a result of IURA, reporting sites 

will submit either a full report for a 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 885

chemical (which includes site 

identification, manufacturing 

information and processing and use 

data) or a partial report (which does not 

include processing and use data). For 

the first reporting cycle, inorganic 

chemical manufacturers will only 

submit partial reports while organic 

chemical manufacturers will submit a 

mix of partial and full reports. The 

IURA increases the average reporting 

burden for both partial and full reports 

compared to previous IUR reporting. 

Companies will continue to report 

under IURA once every 4 years, so the 

average annual IURA reporting burden 

and cost is calculated in the ICR as one 

quarter of the burden and cost in a 

reporting cycle. Thus, the results in the 

ICR differ slightly from those in the 

economic analysis prepared under 

Executive Order 12866, which 

calculates the annualized cost of 

multiple reporting cycles over a 20–year 

period. In addition, the economic 

analysis calculates the incremental 

increase in burden due to IURA, while 

the ICR calculates the total reporting 

and recordkeeping burden for IURA 

(i.e., the sum of the incremental IURA 

burden and the baseline IUR burden). 

Companies may continue to report for 

multiple chemicals on a single Form U 

(as revised). Companies generally 

submit one Form U per site, so the 

burden per Form U is approximately 

equivalent to the burden per site. 

For the first reporting cycle, the 

annual average burden for organic 

chemical manufacturers is estimated to 

be 121.5 to 152.4 hours per site at a cost 

of $8,313 to $10,448 (reflecting an 

average of 5.1 partial reports and 3.8 full 

reports per site). For inorganic chemical 

manufacturers, the annual average 

burden is estimated at 43.3 to 66.1 hours 

per site at a cost of $2,936 to $4,547 

(reflecting an average of 8.3 reports per 

site). These estimates include the time 

needed to review instructions; search 

data sources; gather and maintain the 

data needed; complete and review the 

collection of information; and transmit 

or otherwise disclose the information. 

The actual burden on any specific site 

may be different from this estimate 

depending on the complexity of the site, 

the number of IURA reportable 

chemicals at the site, and the profile of 

the site’s operations. There will be 

approximately 2,500 submitters for 

organic chemicals (including petroleum 

process streams), and 500 submitters for 

inorganic chemicals. For the first 

reporting cycle, the total annual burden 

is estimated to be approximately 

325,000 to 414,000 hours at a total 

estimated industry cost of $22.2 to $28.4 

million per year. 

Under the PRA, ‘‘burden’’ means the 

total time, effort, or financial resources 

expended by persons to generate, 

maintain, retain, or disclose or provide 

information to or for a Federal agency. 

This includes the time needed to: 

Review instructions; develop, acquire, 

install, and utilize technology and 

systems for the purposes of collecting, 

validating, and verifying information, 

processing and maintaining 

information, and disclosing and 

providing information; adjust the 

existing ways to comply with any 

previously applicable instructions and 

requirements; train personnel to be able 

to respond to a collection of 

information; search data sources; 

complete and review the collection of 

information; and transmit or otherwise 

disclose the information. 

As part of the PRA approval renewal 

process, which occurs every 3 years and 

includes an opportunity for public 

review and comment prior to OMB 

review, EPA intends to evaluate this 

collection activity, particularly the new 

exemption process, in order to 

demonstrate the practical utility of 

IURA information collection activities. 

The Agency will provide information in 

the ICR renewal document that details 

the chemicals evaluated under the 

exemption process, the exemption 

requests received, and the Agency’s 

decisions made, as well as provide 

information about the process elements 

and experiences. 

An Agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information 

unless it displays a currently valid OMB 

control number. The currently approved 

ICR control numbers issued by OMB for 

various EPA regulations are listed in 40 

CFR part 9 and 48 CFR chapter 15. EPA 

is amending the table in 40 CFR part 9 

to list the OMB approval number for the 

information collection requirements 

contained in this final rule. This listing 

of the OMB control numbers and their 

subsequent codification in the CFR 

satisfies the display requirements of the 

PRA and OMB’s implementing 

regulations at 5 CFR part 1320. This ICR 

was previously subject to public notice 

and comment prior to OMB approval. 

Due to the technical nature of the table, 

EPA finds that further notice and 

comment is unnecessary. As a result, 

EPA finds that there is ‘‘good cause’’

under section 553(b)(B) of the 

Administrative Procedure Act, 5 U.S.C. 

553(b)(B), to amend this table without 

further notice and comment. 

C. Regulatory Flexibility Act 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (5 U.S.C. 601 

et seq.), the Agency hereby certifies that 

this final rule will not have a significant 

economic impact on a substantial 

number of small entities. The factual 

basis for the Agency’s determination is 

presented in the small entity impact 

analysis prepared as part of the 

economic analysis for this rule (Ref. 6), 

and is briefly summarized here. 

Small entities include small 

businesses, small not-for-profit 

organizations, and small governmental 

jurisdictions (5 U.S.C. 601(6)). Because 

not-for-profit organizations and 

governmental jurisdictions will not be 

affected by this rule, ‘‘small entity’’ for 

purposes of this final rule is 

synonymous with ‘‘small business.’’

Section 601(3) of the RFA establishes as 

the default definition of small business 

the definition used in section 3 of the 

Small Business Act (15 U.S.C. 632) 

under which the Small Business 

Administration (SBA) establishes small 

business size standards (13 CFR 

121.201). The RFA recognizes, however, 

that it may be appropriate at times for 

Federal agencies to use an alternate 

definition of small business. As a result, 

RFA section 601(3) provides that an 

Agency may establish a different 

definition of small business after 

consultation with the SBA Office of 

Advocacy and after notice and an 

opportunity for public comment. EPA 

established a different definition of 

small business, found in the existing 

IUR at 40 CFR 704.3, in accordance with 

these requirements. Manufacturers who 

meet the 40 CFR 704.3 definition of 

small business are generally exempted 

from IUR reporting in 40 CFR 710.29. 

This exemption is retained under these 

amendments in § 710.49 and was not 

reopened for comment. In general, EPA 

strives to minimize potential adverse 

impacts on small entities when 

developing regulations to achieve the 

environmental and human health 

protection goals of the statute and the 

Agency. 

Despite the fact that small 

manufacturers that fully meet the 40 

CFR 704.3 definition are generally 

exempt from reporting under IUR, and 

thus are not significantly impacted by 

IURA, EPA conducted an analysis of the 

potential impact for submitters that 

meet only part of the 40 CFR 704.3 

definition. Specifically, an analysis of 

the potential impact was conducted 

only for those submitters that meet the 

first criterion in the 40 CFR 704.3 

definition of ‘‘small manufacturer or 

importer,’’ i.e., total annual sales of less 

than $40 million, but that do not meet 

the second criterion, i.e., production or 

import volume of less than 100,000 

pounds at all sites. 

886 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

For small manufacturers of organic 

chemicals subject to reporting, the 

Agency estimates the impact to be 

0.15% to 0.18% of sales. For small 

manufacturers of inorganic chemicals 

subject to reporting, the Agency 

estimates the impact to be 0.07% to 

0.20% of sales. 

D. Unfunded Mandates Reform Act 

Pursuant to Title II of the Unfunded 

Mandates Reform Act of 1995 (Public 

Law 104–4), EPA has determined that 

this regulatory action does not contain 

a Federal mandate that may result in 

expenditures of $100 million or more 

for State, local, and tribal governments, 

in the aggregate, or for the private sector 

in any 1 year. The analysis of the costs 

associated with this action are described 

in Unit V.A. In addition, EPA has 

determined that this rule does not 

significantly or uniquely affect small 

governments. Accordingly, this rule is 

not subject to the requirements of 

sections 202, 203, 204, and 205 of 

UMRA. 

E. Executive Order 13132 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999), requires EPA to develop an 

accountable process to ensure 

‘‘meaningful and timely input by State 

and local officials in the development of 

regulatory policies that have federalism 

implications.’’ ‘‘Policies that have 

federalism implications’’ is defined in 

the Executive Order to include 

regulations that have ‘‘substantial direct 

effects on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government.’’

This final rule does not have 

federalism implications, because it will 

not have substantial direct effects on the 

States, on the relationship between the 

national government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132. Thus, Executive 

Order 13132 does not apply to this rule. 

F. Executive Orders 13084 and 13175 

Under Executive Order 13084, 

entitled Consultation and Coordination 

with Indian Tribal Governments (63 FR 

27655, May 19, 1998), EPA may not 

issue a regulation that is not required by 

statute, that significantly or uniquely 

affects the communities of Indian tribal 

governments, and that imposes 

substantial direct compliance costs on 

those communities, unless the Federal 

government provides the funds 

necessary to pay the direct compliance 

costs incurred by the tribal 

governments, or EPA consults with 

those governments. 

If EPA complies by consulting, 

Executive Order 13084 requires EPA to 

provide to OMB, in a separately 

identified section of the preamble to the 

rule, a description of the extent of EPA’s 

prior consultation with representatives 

of affected tribal governments, a 

summary of the nature of their concerns, 

and a statement supporting the need to 

issue the regulation. In addition, 

Executive Order 13084 requires EPA to 

develop an effective process permitting 

elected officials and other 

representatives of Indian tribal 

governments ‘‘to provide meaningful 

and timely input in the development of 

regulatory policies on matters that 

significantly or uniquely affect their 

communities.’’

This rule does not significantly or 

uniquely affect the communities of 

Indian tribal governments, nor does it 

impose substantial direct compliance 

costs on such communities. 

Accordingly, the requirements of 

section 3(b) of Executive Order 13084 

do not apply to this rule. 

On November 6, 2000, the President 

issued Executive Order 13175, entitled 

Consultation and Coordination with 

Indian Tribal Governments (65 FR 

67249). Executive Order 13175 took 

effect on January 6, 2001, and revokes 

Executive Order 13084 as of that date. 

EPA developed this rule, however, 

during the period when Executive Order 

13084 was in effect; thus, EPA 

addressed tribal considerations under 

Executive Order 13084. 

G. Executive Order 13211

This rule is not a ‘‘significant energy 

action’’ as defined in Executive Order 

13211, Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) because it is not likely to have 

a significant adverse effect on the 

supply, distribution, or use of energy. 

This final rule modifies the existing IUR 

reporting and recordkeeping 

requirements that apply to chemical 

manufacturers and importers. As such, 

we have concluded that this rule is not 

likely to have adverse energy effects. 

H. Executive Order 13045 

This rulemaking does not require 

special consideration pursuant to the 

terms of Executive Order 13045, entitled 

Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997), 

because it is not likely to have an 

annual effect on the economy of $100 

million or more and it does not have a 

potential effect or impact on children. 

As discussed in this preamble, this rule 

will provide the Agency with 

information needed to screen and 

prioritize chemical substances, 

including information on potential 

exposures to children. This information 

will allow the Agency and others to 

determine which chemical substances 

have potential risks, allowing the 

Agency and others to take appropriate 

action to investigate and mitigate those 

risks. 

I. National Technology Transfer and 

Amendment Act 

This regulatory action does not 

involve any technical standards that 

would require Agency consideration of 

voluntary consensus standards pursuant 

to section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (NTTAA), Public Law 104–

113, 12(d) (15 U.S.C. 272 note). Section 

12(d) of NTTAA directs EPA to use 

voluntary consensus standards in its 

regulatory activities unless to do so 

would be inconsistent with applicable 

law or otherwise impractical. Voluntary 

consensus standards are technical 

standards (e.g., materials specifications, 

test methods, sampling procedures, and 

business practices) that are developed or 

adopted by voluntary consensus 

standards bodies. The NTTAA requires 

EPA to provide Congress, through OMB, 

explanations when the Agency decides 

not to use available and applicable 

voluntary consensus standards. 

J. Executive Order 12898

Pursuant to Executive Order 12898, 

entitled Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994), the Agency has considered 

environmental justice-related issues 

with regard to the potential impacts of 

this action on the environmental and 

health conditions in minority and lowincome populations. The Agency 

believes that the information collected 

under this rule will assist EPA and 

others in determining the risks and 

exposures associated with the chemicals 

covered by the rule. Although not 

directly impacting environmental 

justice-related concerns, this 

information will enable the Agency to 

protect human health and the 

environment by being better able to 

prioritize chemical substances of 

concern. 

K. Executive Order 12630

EPA has complied with Executive 

Order 12630, entitled Governmental 

Actions and Interference with 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 887

Constitutionally Protected Property 

Rights (53 FR 8859, March 15, 1988), by 

examining the takings implications of 

this rule in accordance with the 

‘‘Attorney General’s Supplemental 

Guidelines for the Evaluation of Risk 

and Avoidance of Unanticipated 

Takings’’ issued under the Executive 

Order. 

L. Executive Order 12988 

In issuing this rule, EPA has taken the 

necessary steps to eliminate drafting 

errors and ambiguity, minimize 

potential litigation, and provide a clear 

legal standard for affected conduct, as 

required by section 3 of Executive Order 

12988, titled Civil Justice Reform (61 FR 

4729, February 7, 1996). 

VI. Submission to Congress and the 

Comptroller General 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

Agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and the Comptroller General of 

the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. This rule is not a 

‘‘major rule’’ as defined by 5 U.S.C. 

804(2).

List of Subjects in 40 CFR Part 9

Environmental protection, Reporting 

and recordkeeping requirements.

List of Subjects in 40 CFR Part 710

Environmental protection, Chemicals, 

Hazardous materials, Reporting and 

recordkeeping requirements.

List of Subjects in 40 CFR Part 723

Environmental protection, Chemicals, 

Hazardous materials, Reporting and 

recordkeeping requirements.

Dated: December 18, 2002. 

Stephen L. Johnson, 

Assistant Administrator for Prevention, 

Pesticides and Toxic Substances.

Therefore, 40 CFR chapter I is 

amended as follows: 

1. Part 9 is amended as follows:

PART 9—[AMENDED] 

a. The authority citation for part 9 

continues to read as follows:

Authority: 7 U.S.C. 135 et seq., 136-136y; 

15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671, 

21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 

U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 

1321, 1326, 1330, 1342, 1344, 1345 (d) and 

(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 

1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 

243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 

300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 

300j-4, 300j-9, 1857 et seq., 6901-6992k, 

7401-7671q, 7542, 9601-9657, 11023, 11048.

b. In § 9.1, the table is amended by 

revising the heading ‘‘Inventory 

Reporting Regulations’’ to read ‘‘TSCA 

Chemical Inventory Regulations’’; 

removing the existing entry under the 

heading; and adding the following 

entries to read as follows:

§ 9.1 OMB approvals under the Paperwork 

Reduction Act.

* * * * *

40 CFR citation OMB Control No. 

*****

TSCA Chemical Inventory Regulations 

Part 710, Subpart B.2070–0070

Part 710, Subpart C.2070–0162 

*****

* * * * *

2. Part 710 is amended as follows:

PART 710—[AMENDED] 

a. The authority citation for part 710 

continues to read as follows:

Authority: 15 U.S.C. 2607(a).

b. Revise the part heading and table 

of contents for part 710 to read as 

follows:

PART 710—TSCA CHEMICAL 

INVENTORY REGULATIONS

Subpart A—General Provisions 

Sec. 

710.1 Scope and compliance. 

710.3 Definitions. 

710.4 Scope of the inventory.

Subpart B—2002 Inventory Update 

Reporting 

710.23 Definitions. 

710.25 Chemical substances for which 

information must be reported. 

710.26 Chemical substances for which 

information is not required. 

710.28 Persons who must report. 

710.29 Persons not subject to this 

subpart. 

710.30 Activities for which reporting 

is not required. 

710.32 Reporting information to EPA. 

710.33 When to report. 

710.35 Duplicative reporting. 

710.37 Recordkeeping requirements. 

710.38 Confidentiality. 

710.39 How do I submit the required 

information?

Subpart C—Inventory Update 

Reporting for 2006 and Beyond 

710.43 Definitions. 

710.45 Chemical substances for which 

information must be reported. 

710.46 Chemical substances for which 

information is not required. 

710.48 Persons who must report. 

710.49 Persons not subject to this 

subpart. 

710.50 Activities for which reporting 

is not required. 

710.52 Reporting information to EPA. 

710.53 When to report. 

710.55 Duplicative reporting. 

710.57 Recordkeeping requirements. 

710.58 Confidentiality. 

710.59 Availability of reporting form 

and instructions. 

c. Sections 710.1 through 710.4 are 

designated as subpart A and the subpart 

heading is added to read as follows:

Subpart A—General Provisions 

d. Revise § 710.1 to read as follows:

§ 710.1 Scope and compliance. 

(a) This part establishes regulations 

governing reporting and recordkeeping 

by certain persons who manufacture, 

import, or process chemical substances 

for commercial purposes under section 

8(a) of the Toxic Substances Control Act 

(15 U.S.C. 2607(a)) (TSCA). Section 8(a) 

authorizes the Administrator to require 

reporting of information necessary for 

administration of the Act and requires 

EPA to issue regulations for the purpose 

of compiling and keeping current an 

inventory of chemical substances 

manufactured or processed for a 

commercial purpose, as required by 

section 8(b) of the Act. Following an 

initial reporting period, EPA published 

an initial inventory of chemical 

substances manufactured, processed, or 

imported for commercial purposes. In 

accordance with section 8(b), EPA 

periodically amends the inventory to 

include new chemical substances which 

are manufactured or imported for a 

commercial purpose and reported under 

section 5(a)(1) of the Act. EPA also 

revises the categories of chemical 

substances and makes other 

amendments as appropriate. 

(b) The regulations in this part apply 

to the activities associated with the 

compilation of the TSCA Chemical 

Inventory and the update of information 

on a subset of the chemical substances 

included on the Inventory. The 

Inventory Update regulations were 

888 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

amended in 2002; however, these 

amendments apply to updates after 

2002, not to the 2002 update. In order 

to prevent confusion as to which 

regulations apply to which update, EPA 

has preserved the provisions that apply 

to the 2002 update in subpart B. The 

new and revised requirements that 

apply to updates after 2002 appear in 

subpart C. Prior to January 1, 2003, the 

regulations in subpart B of this part are 

effective for purposes of Inventory 

update activities. As of January 1, 2003, 

subpart C is effective for purposes of 

Inventory update activities. The Agency 

intends to remove subpart B from the 

CFR once the 2002 update is complete. 

(c) Section 15(3) of TSCA makes it 

unlawful for any person to fail or refuse 

to submit information required under 

these reporting regulations. In addition, 

section 15(3) makes it unlawful for any 

person to fail to keep, and permit access 

to, records required by these 

regulations. Section 16 provides that 

any person who violates a provision of 

section 15 is liable to the United States 

for a civil penalty and may be 

criminally prosecuted. Pursuant to 

section 17, the Government may seek 

judicial relief to compel submission of 

section 8(a) information and to 

otherwise restrain any violation of 

section 15. (EPA does not intend to 

concentrate its enforcement efforts on 

insignificant clerical errors in 

reporting.) 

(d) Each person who reports under 

these regulations must maintain records 

that document information reported 

under these regulations and, in 

accordance with the Act, permit access 

to, and the copying of, such records by 

EPA officials.

§ 710.2 [Removed] 

e. Remove § 710.2. 

f. Add § 710.3 to subpart A to read as 

follows:

§ 710.3 Definitions. 

In addition to the definitions in 

§ 704.3 of this chapter, the following 

definitions apply to this part: 

(a) The following terms will have the 

meaning contained in the Federal Food, 

Drug, and Cosmetic Act, 21 U.S.C. 321 

et seq., and the regulations issued under 

such Act: Cosmetic, device, drug, food, 

and food additive. In addition, the term 

food includes poultry and poultry 

products, as defined in the Poultry 

Products Inspection Act, 21 U.S.C. 453 

et seq.; meats and meat food products, 

as defined in the Federal Meat 

Inspection Act, 21 U.S.C. 60 et seq.; and 

eggs and egg products, as defined in the 

Egg Products Inspection Act, 21 U.S.C. 

1033 et seq. 

(b) The term pesticide will have the 

meaning contained in the Federal 

Insecticide, Fungicide, and Rodenticide 

Act, 7 U.S.C. 136 et seq., and the 

regulations issued thereunder. 

(c) The following terms will have the 

meaning contained in the Atomic 

Energy Act of 1954, 42 U.S.C. 2014 et 

seq., and the regulations issued 

thereunder: Byproduct material, source 

material, and special nuclear material. 

(d) The following definitions also 

apply to this part: 

Act means the Toxic Substances 

Control Act, 15 U.S.C. 2601 et seq. 

Administrator means the 

Administrator of the U.S. 

Environmental Protection Agency, any 

employee or authorized representative 

of the Agency to whom the 

Administrator may either herein or by 

order delegate his/her authority to carry 

out his/her functions, or any other 

person who will by operation of law be 

authorized to carry out such functions. 

An article is a manufactured item: 

(1) Which is formed to a specific 

shape or design during manufacture, 

(2) Which has end use function(s) 

dependent in whole or in part upon its 

shape or design during end use, and 

(3) Which has either no change of 

chemical composition during its end 

use or only those changes of 

composition which have no commercial 

purpose separate from that of the article 

and that may occur as described in 

§ 710.4(d)(5); except that fluids and 

particles are not considered articles 

regardless of shape or design. 

Byproduct means a chemical 

substance produced without separate 

commercial intent during the 

manufacture or processing of another 

chemical substance(s) or mixture(s). 

Chemical substance means any 

organic or inorganic substance of a 

particular molecular identity, including 

any combination of such substances 

occurring in whole or in part as a result 

of a chemical reaction or occurring in 

nature, and any chemical element or 

uncombined radical; except that 

‘‘chemical substance’’ does not include: 

(1) Any mixture, 

(2) Any pesticide when manufactured, 

processed, or distributed in commerce 

for use as a pesticide, 

(3) Tobacco or any tobacco product, 

but not including any derivative 

products, 

(4) Any source material, special 

nuclear material, or byproduct material, 

(5) Any pistol, firearm, revolver, 

shells, and cartridges, and 

(6) Any food, food additive, drug, 

cosmetic, or device, when 

manufactured, processed, or distributed 

in commerce for use as a food, food 

additive, drug, cosmetic, or device. 

Commerce means trade, traffic, 

transportation, or other commerce: 

(1) Between a place in a State and any 

place outside of such State, or 

(2) Which affects trade, traffic, 

transportation, or commerce described 

in paragraph (1) of this definition. 

Distribute in commerce and 

distribution in commerce, when used to 

describe an action taken with respect to 

a chemical substance or mixture or 

article containing a substance or 

mixture, mean to sell or the sale of the 

substance, mixture, or article in 

commerce; to introduce or deliver for 

introduction into commerce, or the 

introduction or delivery for introduction 

into commerce of the substance, 

mixture, or article; or to hold or the 

holding of the substance, mixture, or 

article after its introduction into 

commerce. 

EPA means the U.S. Environmental 

Protection Agency. 

Importer means any person who 

imports any chemical substance or any 

chemical substance as part of a mixture 

or article into the customs territory of 

the U.S. and includes: 

(1) The person primarily liable for the 

payment of any duties on the 

merchandise, or 

(2) An authorized agent acting on his/

her behalf (as defined in 19 CFR 1.11). 

Impurity means a chemical substance 

which is unintentionally present with 

another chemical substance. 

Intermediate means any chemical 

substance: 

(1) Which is intentionally removed 

from the equipment in which it is 

manufactured, and 

(2) Which either is consumed in 

whole or in part in chemical reaction(s) 

used for the intentional manufacture of 

other chemical substance(s) or 

mixture(s), or is intentionally present 

for the purpose of altering the rate of 

such chemical reaction(s).

Note: The equipment in which it was 

manufactured includes the reaction vessel in 

which the chemical substance was 

manufactured and other equipment which is 

strictly ancillary to the reaction vessel, and 

any other equipment through which the 

chemical substance may flow during a 

continuous flow process, but does not 

include tanks or other vessels in which the 

chemical substance is stored after its 

manufacture.

Manufacture means to manufacture, 

produce, or import for commercial 

purposes. 

Manufacture or import ‘‘for 

commercial purposes’’ means to 

manufacture, produce, or import with 

the purpose of obtaining an immediate 

or eventual commercial advantage, and 

includes, for example, the manufacture 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 889

or import of any amount of a chemical 

substance or mixture: 

(1) For commercial distribution, 

including for test marketing, or 

(2) For use by the manufacturer, 

including use for product research and 

development, or as an intermediate. 

Mixture means any combination of 

two or more chemical substances if the 

combination does not occur in nature 

and is not, in whole or in part, the result 

of a chemical reaction; except that 

‘‘mixture’’ does include: 

(1) Any combination which occurs, in 

whole or in part, as a result of a 

chemical reaction if the combination 

could have been manufactured for 

commercial purposes without a 

chemical reaction at the time the 

chemical substances comprising the 

combination were combined and if, after 

the effective date or premanufacture 

notification requirements, none of the 

chemical substances comprising the 

combination is a new chemical 

substance, and 

(2) Hydrates of a chemical substance 

or hydrated ions formed by association 

of a chemical substance with water. 

New chemical substance means any 

chemical substance which is not 

included in the inventory compiled and 

published under section 8(b) of the Act. 

Person means any natural or juridical 

person including any individual, 

corporation, partnership, or association, 

any State or political subdivision 

thereof, or any municipality, any 

interstate body and any department, 

agency, or instrumentality of the Federal 

Government. 

Process means the preparation of a 

chemical substance or mixture, after its 

manufacture, for distribution in 

commerce: 

(1) In the same form or physical state 

as, or in a different form or physical 

state from, that in which it was received 

by the person so preparing such 

substance or mixture, or 

(2) As part of a mixture or article 

containing the chemical substance or 

mixture. 

Process ‘‘for commercial purposes’’

means to process: 

(1) For distribution in commerce, 

including for test marketing purposes, 

or 

(2) For use as an intermediate. 

Processor means any person who 

processes a chemical substance or 

mixture. 

Site means a contiguous property 

unit. Property divided only by a public 

right-of-way will be considered one site. 

There may be more than one 

manufacturing plant on a single site. For 

the purposes of imported chemical 

substances, the site will be the business 

address of the importer. 

Small quantities for purposes of 

scientific experimentation or analysis or 

chemical research on, or analysis of, 

such substance or another substance, 

including any such research or analysis 

for the development of a product

(hereinafter sometimes shortened to 

small quantities for research and 

development) means quantities of a 

chemical substance manufactured, 

imported, or processed or proposed to 

be manufactured, imported, or 

processed that: 

(1) Are no greater than reasonably 

necessary for such purposes, and 

(2) After the publication of the revised 

inventory, are used by, or directly under 

the supervision of, a technically 

qualified individual(s).

Note: Any chemical substances 

manufactured, imported, or processed in 

quantities less than 1,000 lbs. (454 kg) 

annually will be presumed to be 

manufactured, imported, or processed for 

research and development purposes. No 

person may report for the inventory any 

chemical substance in such quantities unless 

that person can certify that the substance was 

not manufactured, imported, or processed 

solely in small quantities for research and 

development, as defined in this section.

State means any State of the United 

States, the District of Columbia, the 

Commonwealth of Puerto Rico, the 

Virgin Islands, Guam, the Canal Zone, 

American Samoa, the Northern Mariana 

Islands, or any other territory or 

possession of the United States. 

Technically qualified individual

means a person: 

(1) Who because of his/her education, 

training, or experience, or a 

combination of these factors, is capable 

of appreciating the health and 

environmental risks associated with the 

chemical substance which is used under 

his/her supervision, 

(2) Who is responsible for enforcing 

appropriate methods of conducting 

scientific experimentation, analysis, or 

chemical research in order to minimize 

such risks, and 

(3) Who is responsible for the safety 

assessments and clearances related to 

the procurement, storage, use, and 

disposal of the chemical substance as 

may be appropriate or required within 

the scope of conducting the research 

and development activity. The 

responsibilities in this paragraph may 

be delegated to another individual, or 

other individuals, as long as each meets 

the criteria in paragraph (1) of this 

definition. 

Test marketing means the distribution 

in commerce of no more than a 

predetermined amount of a chemical 

substance, mixture, or article containing 

that chemical substance or mixture, by 

a manufacturer or processor to no more 

than a defined number of potential 

customers to explore market capability 

in a competitive situation during a 

predetermined testing period prior to 

the broader distribution of that chemical 

substance, mixture, or article in 

commerce. 

United States, when used in the 

geographic sense, means all of the 

States, territories, and possessions of the 

United States.

§ 710.4 [Amended] 

g. Section 710.4 is amended as 

follows: 

i. In paragraphs (a), (c)(1), (c)(2), 

(c)(3), and the Note at the end of 

paragraph (d)(8), change the references 

to ‘‘§ 710.2’’, ‘‘§ 710.2(h)’’, ‘‘§ 710.2(q)’’, 

‘‘§ 710.2(y)’’, and ‘‘§ 710.2(n)’’, 

respectively to ‘‘§ 710.3(d)’’. 

ii. In paragraph (b)(2), change ‘‘shall’’

to ‘‘will’’. 

iii. In the Note to paragraph (d)(2), 

change ‘‘premanufacturing’’ to 

‘‘premanufacture’’. 

iv. In paragraph (d)(5), change 

‘‘photographic, films’’ to ‘‘photographic 

films’’. 

h. Sections 710.25 through 710.39 are 

designated as subpart B and the subpart 

heading is added to read as follows:

Subpart B—2002 Inventory Update 

Reporting 

i. Add § 710.23 to subpart B to read 

as follows:

§ 710.23 Definitions. 

In addition to the definitions in 

§ 704.3 of this chapter and § 710.3, the 

following definitions also apply to 

subpart B of this part. 

Master Inventory File means EPA’s 

comprehensive list of chemical 

substances which constitute the 

Chemical Substances Inventory 

compiled under section 8(b) of the Act. 

It includes substances reported under 

subpart A of this part and substances 

reported under part 720 of this chapter 

for which a Notice of Commencement of 

Manufacture or Import has been 

received under § 720.120 of this chapter. 

Non-isolated intermediate means any 

intermediate that is not intentionally 

removed from the equipment in which 

it is manufactured, including the 

reaction vessel in which it is 

manufactured, equipment which is 

ancillary to the reaction vessel, and any 

equipment through which the substance 

passes during a continuous flow 

process, but not including tanks or other 

vessels in which the substance is stored 

after its manufacture. 

890 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

Site-limited means a chemical 

substance is manufactured and 

processed only within a site and is not 

distributed for commercial purposes as 

a substance or as part of a mixture or 

article outside the site. Imported 

substances are never site-limited.

§ 710.39 [Amended] 

j. Section 710.39 is amended as 

follows: 

i. Revise the section heading to read 

‘‘How do I submit the required 

information?’’

ii. In paragraph (a), the second 

sentence is revised to read: ‘‘Copies of 

the Form U are available from EPA at 

the address set forth in paragraph (c) of 

this section and from the EPA Internet 

Home Page at http://www.epa.gov/oppt/

iur/iur02/index.htm.’’

iii. In the introductory text of 

paragraph (c), change ‘‘1994’’ to ‘‘1998’’. 

iv. In paragraph (c)(1), insert a period 

after ‘‘554–1404’’ and remove the 

remainder of the sentence. 

v. In paragraph (c)(3), change ‘‘7408,’’

to ‘‘7408M,’’. 

vi. In paragraph (d), change 

‘‘Document Control Officer’’ to ‘‘OPPT 

Document Control Officer’’ and change 

‘‘7407,’’ to ‘‘7407M,’’. 

k. Add a new subpart C to read as 

follows:

Subpart C—Inventory Update 

Reporting for 2006 and Beyond

§ 710.43 Definitions. 

In addition to the definitions in 

§ 704.3 of this chapter and § 710.3, the 

following definitions also apply to 

subpart C of this part: 

Commercial use means the use of a 

chemical substance or mixture in a 

commercial enterprise providing 

saleable goods or services (e.g., dry 

cleaning establishment, painting 

contractor). 

Consumer use means the use of a 

chemical substance that is directly, or as 

part of a mixture, sold to or made 

available to consumers for their use in 

or around a permanent or temporary 

household or residence, in or around a 

school, or in or around recreational 

areas. 

Industrial use means use at a site at 

which one or more chemical substances 

or mixtures are manufactured (including 

imported) or processed. 

Intended for use by children means 

the chemical substance or mixture is 

used in or on a product that is 

specifically intended for use by children 

age 14 or younger. A chemical substance 

or mixture is intended for use by 

children when the submitter answers 

‘‘yes’’ to at least one of the following 

questions for the product into which the 

submitter’s chemical substance or 

mixture is incorporated: 

(1) Is the product commonly 

recognized (i.e., by a reasonable person) 

as being intended for children age 14 or 

younger? 

(2) Does the manufacturer of the 

product state through product labeling 

or other written materials that the 

product is intended for or will be used 

by children age 14 or younger? 

(3) Is the advertising, promotion, or 

marketing of the product aimed at 

children age 14 or younger? 

Known to or reasonably ascertainable 

by means all information in a person’s 

possession or control, plus all 

information that a reasonable person 

similarly situated might be expected to 

possess, control, or know. 

Master Inventory File means EPA’s 

comprehensive list of chemical 

substances which constitute the 

Chemical Substances Inventory 

compiled under section 8(b) of the Act. 

It includes substances reported under 

subpart A of this part and substances 

reported under part 720 of this chapter 

for which a Notice of Commencement of 

Manufacture or Import has been 

received under § 720.120 of this chapter. 

Non-isolated intermediate means any 

intermediate that is not intentionally 

removed from the equipment in which 

it is manufactured, including the 

reaction vessel in which it is 

manufactured, equipment which is 

ancillary to the reaction vessel, and any 

equipment through which the substance 

passes during a continuous flow 

process, but not including tanks or other 

vessels in which the substance is stored 

after its manufacture. 

Readily obtainable information means 

information which is known by 

management and supervisory employees 

of the submitter company who are 

responsible for manufacturing, 

processing, distributing, technical 

services, and marketing of the reportable 

chemical substance. Extensive file 

searches are not required. 

Reasonably likely to be exposed

means an exposure to a chemical 

substance which, under foreseeable 

conditions of manufacture (including 

import), processing, distribution in 

commerce, or use of the chemical 

substance, is more likely to occur than 

not to occur. Such exposures would 

normally include, but would not be 

limited to, activities such as charging 

reactor vessels, drumming, bulk loading, 

cleaning equipment, maintenance 

operations, materials handling and 

transfers, and analytical operations. 

Covered exposures include exposures 

through any route of entry (inhalation, 

ingestion, skin contact, absorption, etc.), 

but excludes accidental or theoretical 

exposures. 

Repackaging means the physical 

transfer of a chemical substance or 

mixture, as is, from one container to 

another container or containers in 

preparation for distribution of the 

chemical substance or mixture in 

commerce. 

Reportable chemical substance means 

a chemical substance described in 

§ 710.45. 

Reporting year means the calendar 

year in which information to be 

reported to EPA during an IUR 

submission period is generated, i.e., 

calendar year 2005 and the calendar 

year at 4–year intervals thereafter. 

Site-limited means a chemical 

substance is manufactured and 

processed only within a site and is not 

distributed for commercial purposes as 

a substance or as part of a mixture or 

article outside the site. Imported 

substances are never site-limited. 

Although a site-limited chemical 

substance is not distributed for 

commercial purposes outside the site at 

which it is manufactured and processed, 

the substance is considered to have been 

manufactured and processed for 

commercial purposes. 

Submission period means the period 

in which the information generated 

during the reporting year is submitted to 

EPA. 

Use means any utilization of a 

chemical substance or mixture that is 

not otherwise covered by the terms 

manufacture or process. Relabeling or 

redistributing a container holding a 

chemical substance or mixture where no 

repackaging of the chemical substance 

or mixture occurs does not constitute 

use or processing of the chemical 

substance or mixture.

§ 710.45 Chemical substances for which 

information must be reported. 

Any chemical substance which is in 

the Master Inventory File at the 

beginning of a submission period 

described in § 710.53, unless the 

chemical substance is specifically 

excluded by § 710.46.

§ 710.46 Chemical substances for which 

information is not required. 

The following groups or categories of 

chemical substances are exempted from 

some or all of the reporting 

requirements of this subpart, with the 

following exception: A chemical 

substance described in paragraph (a)(1), 

(a)(2), or (a)(4), or (b) of this section is 

not exempted from any of the reporting 

requirements of this subpart if that 

substance is the subject of a rule 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 891

proposed or promulgated under section 

4, 5(a)(2), 5(b)(4), or 6 of the Act, or is 

the subject of an order issued under 

section 5(e) or 5(f) of the Act, or is the 

subject of relief that has been granted 

under a civil action under section 5 or 

7 of the Act. 

(a) Full exemptions. The following 

categories of chemical substances are 

exempted from the reporting 

requirements of this subpart. 

(1) Polymers. (i) Any chemical 

substance described with the word 

fragments ‘‘*polym*’’, ‘‘*alkyd’’, or 

‘‘*oxylated’’ in the Chemical Abstracts 

Service Index or Preferred 

Nomenclature in the Chemical 

Substance Identities section of the 1985 

edition of the Inventory or in the Master 

Inventory File, where the asterisk (*) 

indicates that any sets of characters may 

precede, or follow, the character string 

defined. 

(ii) Any chemical substance which is 

identified in the 1985 edition of the 

Inventory or the Master Inventory File 

as siloxane and silicone, silsesquioxane, 

a protein (albumin, casein, gelatin, 

gluten, hemoglobin), an enzyme, a 

polysaccharide (starch, cellulose, gum), 

rubber, or lignin. 

(iii) This exclusion does not apply to 

a polymeric substance that has been 

hydrolyzed, depolymerized, or 

otherwise chemically modified, except 

in cases where the intended product of 

this reaction is totally polymeric in 

structure. 

(2) Microorganisms. Any combination 

of chemical substances that is a living 

organism, and that meets the definition 

of ‘‘microorganism’’ at § 725.3 of this 

chapter. Any chemical substance 

produced from a living microorganism 

is reportable under this subpart unless 

otherwise excluded. 

(3) Naturally occurring chemical 

substances. Any naturally occurring 

chemical substance, as described in 

§ 710.4(b). The applicability of this 

exclusion is determined in each case by 

the specific activities of the person who 

manufactures the substance in question. 

Some chemical substances can be 

manufactured both as described in 

§ 710.4(b) and by means other than 

those described in § 710.4(b). If a person 

described in § 710.48 manufactures a 

chemical substance by means other than 

those described in § 710.4(b), the person 

must report regardless of whether the 

substance also could have been 

produced as described in § 710.4(b). 

Any chemical substance that is 

produced from such a naturally 

occurring chemical substance described 

in § 710.4(b) is reportable unless 

otherwise excluded. 

(4) Certain forms of natural gas. 

Chemical substances with the following 

Chemical Abstract Service (CAS) 

Registry Numbers: CAS No. 64741–48–

6, Natural gas (petroleum), raw liquid 

mix; CAS No. 68919–39–1, Natural gas 

condensates; CAS No. 8006–61–9, 

Gasoline natural; CAS No. 68425–31–0, 

Gasoline (natural gas), natural; CAS No. 

8006–14–2, Natural gas; and CAS No. 

68410–63–9, Natural gas, dried. 

(b) Partial exemptions. The following 

groups of chemical substances are 

partially exempted from the reporting 

requirements of this subpart (i.e., the 

information described in § 710.52(c)(4) 

need not be reported for these 

substances). Such chemical substances 

are not excluded from the other 

reporting requirements under this 

subpart. A chemical substance 

described in paragraph (b)(3) of this 

section qualifies for a partial reporting 

exemption during the 2006 submission 

period; in subsequent submission 

periods, the chemical substances 

described in paragraph (b)(3) of this 

section will be subject to full reporting 

under this subpart (i.e., all of the 

information described in this subpart 

must be reported), unless otherwise 

exempted. 

(1) Petroleum process streams. EPA 

has designated the following chemical 

substances, listed by CAS Number, as 

partially exempt from reporting under 

the IUR.

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED ‘‘PETROLEUM PROCESS STREAMS’’ FOR

PURPOSES OF INVENTORY UPDATE REPORTING

CAS No. Product 

7732–18–5 ............... Water 

8002–05–9 ............... Petroleum 

8002–74–2 ............... Paraffin waxes and hydrocarbon waxes 

8006–20–0 ............... Fuel gases, low and medium B.T.U. 

8008–20–6 ............... Kerosine (petroleum) 

8009–03–8 ............... Petrolatum 

8012–95–1 ............... Paraffin oils 

8030–30–6 ............... Naphtha 

8032–32–4 ............... Ligroine 

8042–47–5 ............... White mineral oil (petroleum) 

8052–41–3 ............... Stoddard solvent 

8052–42–4 ............... Asphalt 

63231–60–7 ............. Paraffin waxes and hydrocarbon waxes, microcryst. 

64741–41–9 ............. Naphtha (petroleum), heavy straight-run 

64741–42–0 ............. Naphtha (petroleum), full-range straight-run 

64741–43–1 ............. Gas oils (petroleum), straight-run 

64741–44–2 ............. Distillates (petroleum), straight-run middle 

64741–45–3 ............. Residues (petroleum), atm. tower 

64741–46–4 ............. Naphtha (petroleum), light straight-run 

64741–47–5 ............. Natural gas condensates (petroleum) 

64741–49–7 ............. Condensates (petroleum), vacuum tower 

64741–50–0 ............. Distillates (petroleum), light paraffinic 

64741–51–1 ............. Distillates (petroleum), heavy paraffinic 

64741–52–2 ............. Distillates (petroleum), light naphthenic 

64741–53–3 ............. Distillates (petroleum), heavy naphthenic 

64741–54–4 ............. Naphtha (petroleum), heavy catalytic cracked 

64741–55–5 ............. Naphtha (petroleum), light catalytic cracked 

64741–56–6 ............. Residues (petroleum), vacuum 

64741–57–7 ............. Gas oils (petroleum), heavy vacuum 

64741–58–8 ............. Gas oils (petroleum), light vacuum 

64741–59–9 ............. Distillates (petroleum), light catalytic cracked 

892 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED ‘‘PETROLEUM PROCESS STREAMS’’ FOR

PURPOSES OF INVENTORY UPDATE REPORTING—Continued

CAS No. Product 

64741–60–2 ............. Distillates (petroleum), intermediate catalytic cracked 

64741–61–3 ............. Distillates (petroleum), heavy catalytic cracked 

64741–62–4 ............. Clarified oils (petroleum), catalytic cracked 

64741–63–5 ............. Naphtha (petroleum), light catalytic reformed 

64741–64–6 ............. Naphtha (petroleum), full-range alkylate 

64741–65–7 ............. Naphtha (petroleum), heavy alkylate 

64741–66–8 ............. Naphtha (petroleum), light alkylate 

64741–67–9 ............. Residues (petroleum), catalytic reformer fractionator 

64741–68–0 ............. Naphtha (petroleum), heavy catalytic reformed 

64741–69–1 ............. Naphtha (petroleum), light hydrocracked 

64741–70–4 ............. Naphtha (petroleum), isomerization 

64741–73–7 ............. Distillates (petroleum), alkylate 

64741–74–8 ............. Naphtha (petroleum), light thermal cracked 

64741–75–9 ............. Residues (petroleum), hydrocracked 

64741–76–0 ............. Distillates (petroleum), heavy hydrocracked 

64741–77–1 ............. Distillates (petroleum), light hydrocracked 

64741–78–2 ............. Naphtha (petroleum), heavy hydrocracked 

64741–79–3 ............. Coke (petroleum) 

64741–80–6 ............. Residues (petroleum), thermal cracked 

64741–81–7 ............. Distillates (petroleum), heavy thermal cracked 

64741–82–8 ............. Distillates (petroleum), light thermal cracked 

64741–83–9 ............. Naphtha (petroleum), heavy thermal cracked 

64741–84–0 ............. Naphtha (petroleum), solvent-refined light 

64741–85–1 ............. Raffinates (petroleum), sorption process 

64741–86–2 ............. Distillates (petroleum), sweetened middle 

64741–87–3 ............. Naphtha (petroleum), sweetened 

64741–88–4 ............. Distillates (petroleum), solvent-refined heavy paraffinic 

64741–89–5 ............. Distillates (petroleum), solvent-refined light paraffinic 

64741–90–8 ............. Gas oils (petroleum), solvent-refined 

64741–91–9 ............. Distillates (petroleum), solvent-refined middle 

64741–92–0 ............. Naphtha (petroleum), solvent-refined heavy 

64741–95–3 ............. Residual oils (petroleum), solvent deasphalted 

64741–96–4 ............. Distillates (petroleum), solvent-refined heavy naphthenic 

64741–97–5 ............. Distillates (petroleum), solvent-refined light naphthenic 

64741–98–6 ............. Extracts (petroleum), heavy naphtha solvent 

64741–99–7 ............. Extracts (petroleum), light naphtha solvent 

64742–01–4 ............. Residual oils (petroleum), solvent-refined 

64742–03–6 ............. Extracts (petroleum), light naphthenic distillate solvent 

64742–04–7 ............. Extracts (petroleum), heavy paraffinic distillate solvent 

64742–05–8 ............. Extracts (petroleum), light paraffinic distillate solvent 

64742–06–9 ............. Extracts (petroleum), middle distillate solvent 

64742–07–0 ............. Raffinates (petroleum), residual oil decarbonization 

64742–08–1 ............. Raffinates (petroleum), heavy naphthenic distillate decarbonization 

64742–09–2 ............. Raffinates (petroleum), heavy paraffinic distillate decarbonization 

64742–10–5 ............. Extracts (petroleum), residual oil solvent 

64742–11–6 ............. Extracts (petroleum), heavy naphthenic distillate solvent 

64742–12–7 ............. Gas oils (petroleum), acid-treated 

64742–13–8 ............. Distillates (petroleum), acid-treated middle 

64742–14–9 ............. Distillates (petroleum), acid-treated light 

64742–15–0 ............. Naphtha (petroleum), acid-treated 

64742–16–1 ............. Petroleum resins 

64742–18–3 ............. Distillates (petroleum), acid-treated heavy naphthenic 

64742–19–4 ............. Distillates (petroleum), acid-treated light naphthenic 

64742–20–7 ............. Distillates (petroleum), acid-treated heavy paraffinic 

64742–21–8 ............. Distillates (petroleum), acid-treated light paraffinic 

64742–22–9 ............. Naphtha (petroleum), chemically neutralized heavy 

64742–23–0 ............. Naphtha (petroleum), chemically neutralized light 

64742–24–1 ............. Sludges (petroleum), acid 

64742–25–2 ............. Lubricating oils (petroleum), acid-treated spent 

64742–26–3 ............. Hydrocarbon waxes (petroleum), acid-treated 

64742–27–4 ............. Distillates (petroleum), chemically neutralized heavy paraffinic 

64742–28–5 ............. Distillates (petroleum), chemically neutralized light paraffinic 

64742–29–6 ............. Gas oils (petroleum), chemically neutralized 

64742–30–9 ............. Distillates (petroleum), chemically neutralized middle 

64742–31–0 ............. Distillates (petroleum), chemically neutralized light 

64742–32–1 ............. Lubricating oils (petroleum), chemically neutralized spent 

64742–33–2 ............. Hydrocarbon waxes (petroleum), chemically neutralized 

64742–34–3 ............. Distillates (petroleum), chemically neutralized heavy naphthenic 

64742–35–4 ............. Distillates (petroleum), chemically neutralized light naphthenic 

64742–36–5 ............. Distillates (petroleum), clay-treated heavy paraffinic 

64742–37–6 ............. Distillates (petroleum), clay-treated light paraffinic 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 893

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED ‘‘PETROLEUM PROCESS STREAMS’’ FOR

PURPOSES OF INVENTORY UPDATE REPORTING—Continued

CAS No. Product 

64742–38–7 ............. Distillates (petroleum), clay-treated middle 

64742–39–8 ............. Neutralizing agents (petroleum), spent sodium carbonate 

64742–40–1 ............. Neutralizing agents (petroleum), spent sodium hydroxide 

64742–41–2 ............. Residual oils (petroleum), clay-treated 

64742–42–3 ............. Hydrocarbon waxes (petroleum), clay-treated microcryst. 

64742–43–4 ............. Paraffin waxes (petroleum), clay-treated 

64742–44–5 ............. Distillates (petroleum), clay-treated heavy naphthenic 

64742–45–6 ............. Distillates (petroleum), clay-treated light naphthenic 

64742–46–7 ............. Distillates (petroleum), hydrotreated middle 

64742–47–8 ............. Distillates (petroleum), hydrotreated light 

64742–48–9 ............. Naphtha (petroleum), hydrotreated heavy 

64742–49–0 ............. Naphtha (petroleum), hydrotreated light 

64742–50–3 ............. Lubricating oils (petroleum), clay-treated spent 

64742–51–4 ............. Paraffin waxes (petroleum), hydrotreated 

64742–52–5 ............. Distillates (petroleum), hydrotreated heavy naphthenic 

64742–53–6 ............. Distillates (petroleum), hydrotreated light naphthenic 

64742–54–7 ............. Distillates (petroleum), hydrotreated heavy paraffinic 

64742–55–8 ............. Distillates (petroleum), hydrotreated light paraffinic 

64742–56–9 ............. Distillates (petroleum), solvent-dewaxed light paraffinic 

64742–57–0 ............. Residual oils (petroleum), hydrotreated 

64742–58–1 ............. Lubricating oils (petroleum), hydrotreated spent 

64742–59–2 ............. Gas oils (petroleum), hydrotreated vacuum 

64742–60–5 ............. Hydrocarbon waxes (petroleum), hydrotreated microcryst. 

64742–61–6 ............. Slack wax (petroleum) 

64742–62–7 ............. Residual oils (petroleum), solvent-dewaxed 

64742–63–8 ............. Distillates (petroleum), solvent-dewaxed heavy naphthenic 

64742–64–9 ............. Distillates (petroleum), solvent-dewaxed light naphthenic 

64742–65–0 ............. Distillates (petroleum), solvent-dewaxed heavy paraffinic 

64742–67–2 ............. Foots oil (petroleum) 

64742–68–3 ............. Naphthenic oils (petroleum), catalytic dewaxed heavy 

64742–69–4 ............. Naphthenic oils (petroleum), catalytic dewaxed light 

64742–70–7 ............. Paraffin oils (petroleum), catalytic dewaxed heavy 

64742–71–8 ............. Paraffin oils (petroleum), catalytic dewaxed light 

64742–72–9 ............. Distillates (petroleum), catalytic dewaxed middle 

64742–73–0 ............. Naphtha (petroleum), hydrodesulfurized light 

64742–75–2 ............. Naphthenic oils (petroleum), complex dewaxed heavy 

64742–76–3 ............. Naphthenic oils (petroleum), complex dewaxed light 

64742–78–5 ............. Residues (petroleum), hydrodesulfurized atmospheric tower 

64742–79–6 ............. Gas oils (petroleum), hydrodesulfurized 

64742–80–9 ............. Distillates (petroleum), hydrodesulfurized middle 

64742–81–0 ............. Kerosine (petroleum), hydrodesulfurized 

64742–82–1 ............. Naphtha (petroleum), hydrodesulfurized heavy 

64742–83–2 ............. Naphtha (petroleum), light steam-cracked 

64742–85–4 ............. Residues (petroleum), hydrodesulfurized vacuum 

64742–86–5 ............. Gas oils (petroleum), hydrodesulfurized heavy vacuum 

64742–87–6 ............. Gas oils (petroleum), hydrodesulfurized light vacuum 

64742–88–7 ............. Solvent naphtha (petroleum), medium aliph. 

64742–89–8 ............. Solvent naphtha (petroleum), light aliph. 

64742–90–1 ............. Residues (petroleum), steam-cracked 

64742–91–2 ............. Distillates (petroleum), steam-cracked 

64742–92–3 ............. Petroleum resins, oxidized 

64742–93–4 ............. Asphalt, oxidized 

64742–94–5 ............. Solvent naphtha (petroleum), heavy arom. 

64742–95–6 ............. Solvent naphtha (petroleum), light arom. 

64742–96–7 ............. Solvent naphtha (petroleum), heavy aliph. 

64742–97–8 ............. Distillates (petroleum), oxidized heavy 

64742–98–9 ............. Distillates (petroleum), oxidized light 

64742–99–0 ............. Residual oils (petroleum), oxidized 

64743–00–6 ............. Hydrocarbon waxes (petroleum), oxidized 

64743–01–7 ............. Petrolatum (petroleum), oxidized 

64743–02–8 ............. Alkenes, C>10 .alpha.-

64743–03–9 ............. Phenols (petroleum) 

64743–04–0 ............. Coke (petroleum), recovery 

64743–05–1 ............. Coke (petroleum), calcined 

64743–06–2 ............. Extracts (petroleum), gas oil solvent 

64743–07–3 ............. Sludges (petroleum), chemically neutralized 

64754–89–8 ............. Naphthenic acids (petroleum), crude 

64771–71–7 ............. Paraffins (petroleum), normal C>10

64771–72–8 ............. Paraffins (petroleum), normal C5-20

67674–12–8 ............. Residual oils (petroleum), oxidized, compounds with triethanolamine 

67674–13–9 ............. Petrolatum (petroleum), oxidized, partially deacidified 

894 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED ‘‘PETROLEUM PROCESS STREAMS’’ FOR

PURPOSES OF INVENTORY UPDATE REPORTING—Continued

CAS No. Product 

67674–15–1 ............. Petrolatum (petroleum), oxidized, Me ester 

67674–16–2 ............. Hydrocarbon waxes (petroleum), oxidized, partially deacidified 

67674–17–3 ............. Distillates (petroleum), oxidized light, compounds with triethanolamine 

67674–18–4 ............. Distillates (petroleum), oxidized light, Bu esters 

67891–79–6 ............. Distillates (petroleum), heavy arom. 

67891–80–9 ............. Distillates (petroleum), light arom. 

67891–82–1 ............. Hydrocarbon waxes (petroleum), oxidized, compounds with ethanolamine 

67891–83–2 ............. Hydrocarbon waxes (petroleum), oxidized, compounds with isopropanolamine 

67891–85–4 ............. Hydrocarbon waxes (petroleum), oxidized, compounds with triisopropanolamine 

68131–05–5 ............. Hydrocarbon oils, process blends 

68131–49–7 ............. Aromatic hydrocarbons, C6-10, acid-treated, neutralized 

68131–75–9 ............. Gases (petroleum), C3-4

68153–22–0 ............. Paraffin waxes and Hydrocarbon waxes, oxidized 

68187–57–5 ............. Pitch, coal tar-petroleum 

68187–58–6 ............. Pitch, petroleum, arom. 

68187–60–0 ............. Hydrocarbons, C4, ethane-propane-cracked 

68307–98–2 ............. Tail gas (petroleum), catalytic cracked distillate and catalytic cracked naphtha fractionation absorber 

68307–99–3 ............. Tail gas (petroleum), catalytic polymn. naphtha fractionation stabilizer 

68308–00–9 ............. Tail gas (petroleum), catalytic reformed naphtha fractionation stabilizer, hydrogen sulfide-free 

68308–01–0 ............. Tail gas (petroleum), cracked distillate hydrotreater stripper 

68308–02–1 ............. Tail gas (petroleum), distn., hydrogen sulfide-free 

68308–03–2 ............. Tail gas (petroleum), gas oil catalytic cracking absorber 

68308–04–3 ............. Tail gas (petroleum), gas recovery plant 

68308–05–4 ............. Tail gas (petroleum), gas recovery plant deethanizer 

68308–06–5 ............. Tail gas (petroleum), hydrodesulfurized distillate and hydrodesulfurized naphtha fractionator, acid-free 

68308–07–6 ............. Tail gas (petroleum), hydrodesulfurized vacuum gas oil stripper, hydrogen sulfide-free 

68308–08–7 ............. Tail gas (petroleum), isomerized naphtha fractionation stabilizer 

68308–09–8 ............. Tail gas (petroleum), light straight-run naphtha stabilizer, hydrogen sulfide-free 

68308–10–1 ............. Tail gas (petroleum), straight-run distillate hydrodesulfurizer, hydrogen sulfide-free 

68308–11–2 ............. Tail gas (petroleum), propane-propylene alkylation feed prep deethanizer 

68308–12–3 ............. Tail gas (petroleum), vacuum gas oil hydrodesulfurizer, hydrogen sulfide-free 

68308–27–0 ............. Fuel gases, refinery 

68333–22–2 ............. Residues (petroleum), atmospheric 

68333–23–3 ............. Naphtha (petroleum), heavy coker 

68333–24–4 ............. Hydrocarbon waxes (petroleum), oxidized, compds. with triethanolamine 

68333–25–5 ............. Distillates (petroleum), hydrodesulfurized light catalytic cracked 

68333–26–6 ............. Clarified oils (petroleum), hydrodesulfurized catalytic cracked 

68333–27–7 ............. Distillates (petroleum), hydrodesulfurized intermediate catalytic cracked 

68333–28–8 ............. Distillates (petroleum), hydrodesulfurized heavy catalytic cracked 

68333–29–9 ............. Residues (petroleum), light naphtha solvent extracts 

68333–30–2 ............. Distillates (petroleum), oxidized heavy thermal cracked 

68333–81–3 ............. Alkanes, C4-12

68333–88–0 ............. Aromatic hydrocarbons, C9-17

68334–30–5 ............. Fuels, diesel 

68409–99–4 ............. Gases (petroleum), catalytic cracked overheads 

68410–00–4 ............. Distillates (petroleum), crude oil 

68410–05–9 ............. Distillates (petroleum), straight-run light 

68410–12–8 ............. Distillates (petroleum), steam-cracked, C5-10 fraction, high-temp. stripping products with light steamcracked petroleum naphtha C5 fraction polymers 

68410–71–9 ............. Raffinates (petroleum), catalytic reformer ethylene glycol-water countercurrent exts. 

68410–96–8 ............. Distillates (petroleum), hydrotreated middle, intermediate boiling 

68410–97–9 ............. Distillates (petroleum), light distillate hydrotreating process, low-boiling 

68410–98–0 ............. Distillates (petroleum), hydrotreated heavy naphtha, deisohexanizer overheads 

68411–00–7 ............. Alkenes, C>8

68425–29–6 ............. Distillates (petroleum), naphtha-raffinate pyrolyzate-derived, gasoline-blending 

68425–33–2 ............. Petrolatum (petroleum), oxidized, barium salt 

68425–34–3 ............. Petrolatum (petroleum), oxidized, calcium salt 

68425–35–4 ............. Raffinates (petroleum), reformer, Lurgi unit-sepd. 

68425–39–8 ............. Alkenes, C>10 .alpha.-, oxidized 

68441–09–8 ............. Hydrocarbon waxes (petroleum), clay-treated microcryst., contg. polyethylene, oxidized 

68459–78–9 ............. Alkenes, C18-24 .alpha.-, dimers 

68475–57–0 ............. Alkanes, C1-2

68475–58–1 ............. Alkanes, C2-3

68475–59–2 ............. Alkanes, C3-4

68475–60–5 ............. Alkanes, C4-5

68475–61–6 ............. Alkenes, C5, naphtha-raffinate pyrolyzate-derived 

68475–70–7 ............. Aromatic hydrocarbons, C6-8, naphtha-raffinate pyrolyzate-derived 

68475–79–6 ............. Distillates (petroleum), catalytic reformed depentanizer 

68475–80–9 ............. Distillates (petroleum), light steam-cracked naphtha 

68476–26–6 ............. Fuel gases 

68476–28–8 ............. Fuel gases, C6-8 catalytic reformer 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 895

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED ‘‘PETROLEUM PROCESS STREAMS’’ FOR

PURPOSES OF INVENTORY UPDATE REPORTING—Continued

CAS No. Product 

68476–29–9 ............. Fuel gases, crude oil distillates 

68476–30–2 ............. Fuel oil, no. 2

68476–31–3 ............. Fuel oil, no. 4

68476–32–4 ............. Fuel oil, residues-straight-run gas oils, high-sulfur 

68476–33–5 ............. Fuel oil, residual 

68476–34–6 ............. Fuels, diesel, no. 2

68476–39–1 ............. Hydrocarbons, aliph.-arom.-C4-5-olefinic 

68476–40–4 ............. Hydrocarbons, C3-4

68476–42–6 ............. Hydrocarbons, C4-5

68476–43–7 ............. Hydrocarbons, C4-6, C5-rich 

68476–44–8 ............. Hydrocarbons, C>3

68476–45–9 ............. Hydrocarbons, C5-10 arom. conc., ethylene-manuf.-by-product 

68476–46–0 ............. Hydrocarbons, C3-11, catalytic cracker distillates 

68476–47–1 ............. Hydrocarbons, C2-6, C6-8 catalytic reformer 

68476–49–3 ............. Hydrocarbons, C2-4, C3-rich 

68476–50–6 ............. Hydrocarbons, C≥5, C5-6-rich 

68476–52–8 ............. Hydrocarbons, C4, ethylene-manuf.-by-product 

68476–53–9 ............. Hydrocarbons, C≥20, petroleum wastes 

68476–54–0 ............. Hydrocarbons, C3-5, polymn. unit feed 

68476–55–1 ............. Hydrocarbons, C5-rich 

68476–56–2 ............. Hydrocarbons, cyclic C5 and C6

68476–77–7 ............. Lubricating oils, refined used 

68476–81–3 ............. Paraffin waxes and Hydrocarbon waxes, oxidized, calcium salts 

68476–84–6 ............. Petroleum products, gases, inorg. 

68476–85–7 ............. Petroleum gases, liquefied 

68476–86–8 ............. Petroleum gases, liquefied, sweetened 

68477–25–8 ............. Waste gases, vent gas, C1-6

68477–26–9 ............. Wastes, petroleum 

68477–29–2 ............. Distillates (petroleum), catalytic reformer fractionator residue, high-boiling 

68477–30–5 ............. Distillates (petroleum), catalytic reformer fractionator residue, intermediate-boiling 

68477–31–6 ............. Distillates (petroleum), catalytic reformer fractionator residue, low-boiling 

68477–33–8 ............. Gases (petroleum), C3-4, isobutane-rich 

68477–34–9 ............. Distillates (petroleum), C3-5, 2-methyl-2-butene-rich 

68477–35–0 ............. Distillates (petroleum), C3-6, piperylene-rich 

68477–36–1 ............. Distillates (petroleum), cracked steam-cracked, C5-18 fraction 

68477–38–3 ............. Distillates (petroleum), cracked steam-cracked petroleum distillates 

68477–39–4 ............. Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C8-10 fraction 

68477–40–7 ............. Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C10-12 fraction 

68477–41–8 ............. Gases (petroleum), extractive, C3-5, butadiene-butene-rich 

68477–42–9 ............. Gases (petroleum), extractive, C3-5, butene-isobutylene-rich 

68477–44–1 ............. Distillates (petroleum), heavy naphthenic, mixed with steam-cracked petroleum distillates C5-12 fraction 

68477–47–4 ............. Distillates (petroleum), mixed heavy olefin vacuum, heart-cut 

68477–48–5 ............. Distillates (petroleum), mixed heavy olefin vacuum, low-boiling 

68477–53–2 ............. Distillates (petroleum), steam-cracked, C5-12 fraction 

68477–54–3 ............. Distillates (petroleum), steam-cracked, C8-12 fraction 

68477–55–4 ............. Distillates (petroleum), steam-cracked, C5-10 fraction, mixed with light steam-cracked petroleum naphtha 

C5 fraction 

68477–58–7 ............. Distillates (petroleum), steam-cracked petroleum distillates, C5-18 fraction 

68477–59–8 ............. Distillates (petroleum), steam-cracked petroleum distillates cyclopentadiene conc. 

68477–60–1 ............. Extracts (petroleum), cold-acid 

68477–61–2 ............. Extracts (petroleum), cold-acid, C4-6

68477–62–3 ............. Extracts (petroleum), cold-acid, C3-5, butene-rich 

68477–63–4 ............. Extracts (petroleum), reformer recycle 

68477–64–5 ............. Gases (petroleum), acetylene manuf. off 

68477–65–6 ............. Gases (petroleum), amine system feed 

68477–66–7 ............. Gases (petroleum), benzene unit hydrodesulfurizer off 

68477–67–8 ............. Gases (petroleum), benzene unit recycle, hydrogen-rich 

68477–68–9 ............. Gases (petroleum), blend oil, hydrogen-nitrogen-rich 

68477–69–0 ............. Gases (petroleum), butane splitter overheads 

68477–70–3 ............. Gases (petroleum), C2-3

68477–71–4 ............. Gases (petroleum), catalytic-cracked gas oil depropanizer bottoms, C4-rich acid-free 

68477–72–5 ............. Gases (petroleum), catalytic-cracked naphtha debutanizer bottoms, C3-5-rich 

68477–73–6 ............. Gases (petroleum), catalytic cracked naphtha depropanizer overhead, C3-rich acid-free 

68477–74–7 ............. Gases (petroleum), catalytic cracker 

68477–75–8 ............. Gases (petroleum), catalytic cracker, C1-5-rich 

68477–76–9 ............. Gases (petroleum), catalytic polymd. naphtha stabilizer overhead, C2-4-rich 

68477–77–0 ............. Gases (petroleum), catalytic reformed naphtha stripper overheads 

68477–79–2 ............. Gases (petroleum), catalytic reformer, C1-4-rich 

68477–80–5 ............. Gases (petroleum), C6-8 catalytic reformer recycle 

68477–81–6 ............. Gases (petroleum), C6-8 catalytic reformer 

68477–82–7 ............. Gases (petroleum), C6-8 catalytic reformer recycle, hydrogen-rich 

896 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED ‘‘PETROLEUM PROCESS STREAMS’’ FOR

PURPOSES OF INVENTORY UPDATE REPORTING—Continued

CAS No. Product 

68477–83–8 ............. Gases (petroleum), C3-5 olefinic-paraffinic alkylation feed 

68477–84–9 ............. Gases (petroleum), C2-return stream 

68477–85–0 ............. Gases (petroleum), C4-rich 

68477–86–1 ............. Gases (petroleum), deethanizer overheads 

68477–87–2 ............. Gases (petroleum), deisobutanizer tower overheads 

68477–88–3 ............. Gases (petroleum), deethanizer overheads, C3-rich 

68477–89–4 ............. Distillates (petroleum), depentanizer overheads 

68477–90–7 ............. Gases (petroleum), depropanizer dry, propene-rich 

68477–91–8 ............. Gases (petroleum), depropanizer overheads 

68477–92–9 ............. Gases (petroleum), dry sour, gas-concn.-unit-off 

68477–93–0 ............. Gases (petroleum), gas concn. reabsorber distn. 

68477–94–1 ............. Gases (petroleum), gas recovery plant depropanizer overheads 

68477–95–2 ............. Gases (petroleum), Girbatol unit feed 

68477–96–3 ............. Gases (petroleum), hydrogen absorber off 

68477–97–4 ............. Gases (petroleum), hydrogen-rich 

68478–00–2 ............. Gases (petroleum), recycle, hydrogen-rich 

68478–01–3 ............. Gases (petroleum), reformer make-up, hydrogen-rich 

68478–02–4 ............. Gases (petroleum), reforming hydrotreater 

68478–03–5 ............. Gases (petroleum), reforming hydrotreater, hydrogen-methane-rich 

68478–04–6 ............. Gases (petroleum), reforming hydrotreater make-up, hydrogen-rich 

68478–05–7 ............. Gases (petroleum), thermal cracking distn. 

68478–08–0 ............. Naphtha (petroleum), light steam-cracked, C5-fraction, oligomer conc. 

68478–10–4 ............. Naphtha (petroleum), light steam-cracked, debenzenized, C8-16-cycloalkadiene conc. 

68478–12–6 ............. Residues (petroleum), butane splitter bottoms 

68478–13–7 ............. Residues (petroleum), catalytic reformer fractionator residue distn. 

68478–15–9 ............. Residues (petroleum), C6-8 catalytic reformer 

68478–16–0 ............. Residual oils (petroleum), deisobutanizer tower 

68478–17–1 ............. Residues (petroleum), heavy coker gas oil and vacuum gas oil 

68478–18–2 ............. Residues (petroleum), heavy olefin vacuum 

68478–19–3 ............. Residual oils (petroleum), propene purifn. splitter 

68478–20–6 ............. Residues (petroleum), steam-cracked petroleum distillates cyclopentadiene conc., C4-cyclopentadienefree 

68478–22–8 ............. Tail gas (petroleum), catalytic cracked naphtha stabilization absorber 

68478–24–0 ............. Tail gas (petroleum), catalytic cracker, catalytic reformer and hydrodesulfurizer combined fractionater 

68478–25–1 ............. Tail gas (petroleum), catalytic cracker refractionation absorber 

68478–26–2 ............. Tail gas (petroleum), catalytic reformed naphtha fractionation stabilizer 

68478–27–3 ............. Tail gas (petroleum), catalytic reformed naphtha separator 

68478–28–4 ............. Tail gas (petroleum), catalytic reformed naphtha stabilizer 

68478–29–5 ............. Tail gas (petroleum), cracked distillate hydrotreater separator 

68478–30–8 ............. Tail gas (petroleum), hydrodesulfurized straight-run naphtha separator 

68478–32–0 ............. Tail gas (petroleum), saturate gas plant mixed stream, C4-rich 

68478–33–1 ............. Tail gas (petroleum), saturate gas recovery plant, C1-2-rich 

68478–34–2 ............. Tail gas (petroleum), vacuum residues thermal cracker 

68512–61–8 ............. Residues (petroleum), heavy coker and light vacuum 

68512–62–9 ............. Residues (petroleum), light vacuum 

68512–78–7 ............. Solvent naphtha (petroleum), light arom., hydrotreated 

68512–91–4 ............. Hydrocarbons, C3-4-rich, petroleum distillates 

68513–02–0 ............. Naphtha (petroleum), full-range coker 

68513–11–1 ............. Fuel gases, hydrotreater fractionation, scrubbed 

68513–12–2 ............. Fuel gases, saturate gas unit fractionater-absorber overheads 

68513–13–3 ............. Fuel gases, thermal cracked catalytic cracking residue 

68513–14–4 ............. Gases (petroleum), catalytic reformed straight-run naphtha stabilizer overheads 

68513–15–5 ............. Gases (petroleum), full-range straight-run naphtha dehexanizer off 

68513–16–6 ............. Gases (petroleum), hydrocracking depropanizer off, hydrocarbon-rich 

68513–17–7 ............. Gases (petroleum), light straight-run naphtha stabilizer off 

68513–18–8 ............. Gases (petroleum), reformer effluent high-pressure flash drum off 

68513–19–9 ............. Gases (petroleum), reformer effluent low-pressure flash drum off 

68513–62–2 ............. Disulfides, C5-12-alkyl 

68513–63–3 ............. Distillates (petroleum), catalytic reformed straight-run naphtha overheads 

68513–65–5 ............. Butane, branched and linear 

68513–66–6 ............. Residues (petroleum), alkylation splitter, C4-rich 

68513–67–7 ............. Residues (petroleum), cyclooctadiene bottoms 

68513–68–8 ............. Residues (petroleum), deethanizer tower 

68513–69–9 ............. Residues (petroleum), steam-cracked light 

68513–74–6 ............. Waste gases, ethylene oxide absorber-reactor 

68514–15–8 ............. Gasoline, vapor-recovery 

68514–29–4 ............. Hydrocarbons, amylene feed debutanizer overheads nonextractable raffinates 

68514–31–8 ............. Hydrocarbons, C1-4

68514–32–9 ............. Hydrocarbons, C10 and C12, olefin-rich 

68514–33–0 ............. Hydrocarbons, C12 and C14, olefin-rich 

68514–34–1 ............. Hydrocarbons, C9-14, ethylene-manuf.-by-product 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 897

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED ‘‘PETROLEUM PROCESS STREAMS’’ FOR

PURPOSES OF INVENTORY UPDATE REPORTING—Continued

CAS No. Product 

68514–35–2 ............. Hydrocarbons, C14-30, olefin-rich 

68514–38–5 ............. Hydrocarbons, C4-10-unsatd. 

68514–36–3 ............. Hydrocarbons, C1-4, sweetened 

68514–37–4 ............. Hydrocarbons, C4-5-unsatd. 

68514–79–4 ............. Petroleum products, hydrofiner-powerformer reformates 

68515–25–3 ............. Benzene, C1-9-alkyl derivs. 

68515–26–4 ............. Benzene, di-C12-14-alkyl derivs. 

68515–27–5 ............. Benzene, di-C10-14-alkyl derivs., fractionation overheads, heavy ends 

68515–28–6 ............. Benzene, di-C10-14-alkyl derivs., fractionation overheads, light ends 

68515–29–7 ............. Benzene, di-C10-14-alkyl derivs., fractionation overheads, middle cut 

68515–30–0 ............. Benzene, mono-C20-48-alkyl derivs. 

68515–32–2 ............. Benzene, mono-C12-14-alkyl derivs., fractionation bottoms 

68515–33–3 ............. Benzene, mono-C10-12-alkyl derivs., fractionation bottoms, heavy ends 

68515–34–4 ............. Benzene, mono-C12-14-alkyl derivs., fractionation bottoms, heavy ends 

68515–35–5 ............. Benzene, mono-C10-12-alkyl derivs., fractionation bottoms, light ends 

68515–36–6 ............. Benzene, mono-C12-14-alkyl derivs., fractionation bottoms, light ends 

68516–20–1 ............. Naphtha (petroleum), steam-cracked middle arom. 

68526–52–3 ............. Alkenes, C6

68526–53–4 ............. Alkenes, C6-8, C7-rich 

68526–54–5 ............. Alkenes, C7-9, C8-rich 

68526–55–6 ............. Alkenes, C8-10, C9-rich 

68526–56–7 ............. Alkenes, C9-11, C10-rich 

68526–57–8 ............. Alkenes, C10-12, C11-rich 

68526–58–9 ............. Alkenes, C11-13, C12-rich 

68526–77–2 ............. Aromatic hydrocarbons, ethane cracking scrubber effluent and flare drum 

68526–99–8 ............. Alkenes, C6-9 .alpha.-

68527–00–4 ............. Alkenes, C8-9 .alpha.-

68527–11–7 ............. Alkenes, C5

68527–13–9 ............. Gases (petroleum), acid, ethanolamine scrubber 

68527–14–0 ............. Gases (petroleum), methane-rich off 

68527–15–1 ............. Gases (petroleum), oil refinery gas distn. off 

68527–16–2 ............. Hydrocarbons, C1-3

68527–18–4 ............. Gas oils (petroleum), steam-cracked 

68527–19–5 ............. Hydrocarbons, C1-4, debutanizer fraction 

68527–21–9 ............. Naphtha (petroleum), clay-treated full-range straight-run 

68527–22–0 ............. Naphtha (petroleum), clay-treated light straight-run 

68527–23–1 ............. Naphtha (petroleum), light steam-cracked arom. 

68527–26–4 ............. Naphtha (petroleum), light steam-cracked, debenzenized 

68527–27–5 ............. Naphtha (petroleum), full-range alkylate, butane-contg. 

68553–00–4 ............. Fuel oil, no. 6

68553–14–0 ............. Hydrocarbons, C8-11

68602–79–9 ............. Distillates (petroleum), benzene unit hydrotreater dipentanizer overheads 

68602–81–3 ............. Distillates, hydrocarbon resin prodn. higher boiling 

68602–82–4 ............. Gases (petroleum), benzene unit hydrotreater depentenizer overheads 

68602–83–5 ............. Gases (petroleum), C1-5, wet 

68602–84–6 ............. Gases (petroleum), secondary absorber off, fluidized catalytic cracker overheads fractionater 

68602–96–0 ............. Distillates (petroleum), oxidized light, strong acid components, compds. with diethanolamine 

68602–97–1 ............. Distillates (petroleum), oxidized light, strong acid components, sodium salts 

68602–98–2 ............. Distillates (petroleum), oxidized light, strong acid components 

68602–99–3 ............. Distillates (petroleum), oxidized light, strong acid-free 

68603–00–9 ............. Distillates (petroleum), thermal cracked naphtha and gas oil 

68603–01–0 ............. Distillates (petroleum), thermal cracked naphtha and gas oil, C5-dimer-contg. 

68603–02–1 ............. Distillates (petroleum), thermal cracked naphtha and gas oil, dimerized 

68603–03–2 ............. Distillates (petroleum), thermal cracked naphtha and gas oil, extractive 

68603–08–7 ............. Naphtha (petroleum), arom.-contg. 

68603–09–8 ............. Hydrocarbon waxes (petroleum), oxidized, calcium salts 

68603–10–1 ............. Hydrocarbon waxes (petroleum), oxidized, Me esters, barium salts 

68603–11–2 ............. Hydrocarbon waxes (petroleum), oxidized, Me esters, calcium salts 

68603–12–3 ............. Hydrocarbon waxes (petroleum), oxidized, Me esters, sodium salts 

68603–13–4 ............. Petrolatum (petroleum), oxidized, ester with sorbitol 

68603–14–5 ............. Residual oils (petroleum), oxidized, calcium salts 

68603–31–6 ............. Alkenes, C10, tert-amylene concentrator by-product 

68603–32–7 ............. Alkenes, C15-20 .alpha.-, isomerized 

68606–09–7 ............. Fuel gases, expander off 

68606–10–0 ............. Gasoline, pyrolysis, debutanizer bottoms 

68606–11–1 ............. Gasoline, straight–run, topping-plant 

68606–24–6 ............. Hydrocarbons, C4, butene concentrator by-product 

68606–25–7 ............. Hydrocarbons, C2-4

68606–26–8 ............. Hydrocarbons, C3

68606–27–9 ............. Gases (petroleum), alkylation feed 

68606–28–0 ............. Hydrocarbons, C5 and C10-aliph. and C6-8-arom. 

898 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED ‘‘PETROLEUM PROCESS STREAMS’’ FOR

PURPOSES OF INVENTORY UPDATE REPORTING—Continued

CAS No. Product 

68606–31–5 ............. Hydrocarbons, C3-5, butadiene purifn. by-product 

68606–34–8 ............. Gases (petroleum), depropanizer bottoms fractionation off 

68606–36–0 ............. Hydrocarbons, C5-unsatd. rich, isoprene purifn. by-product 

68607–11–4 ............. Petroleum products, refinery gases 

68607–30–7 ............. Residues (petroleum), topping plant, low-sulfur 

68608–56–0 ............. Waste gases, from carbon black manuf. 

68647-60–9 ............. Hydrocarbons, C>4

68647–61–0 ............. Hydrocarbons, C4-5, tert-amylene concentrator by-product 

68647–62–1 ............. Hydrocarbons, C4-5, butene concentrator by-product, sour 

68650–36–2 ............. Aromatic hydrocarbons, C8, o-xylene-lean 

68650–37–3 ............. Paraffin waxes (petroleum), oxidized, sodium salts 

68782–97–8 ............. Distillates (petroleum), hydrofined lubricating-oil 

68782–98–9 ............. Extracts (petroleum), clarified oil solvent, condensed-ring-arom.-contg. 

68782–99–0 ............. Extracts (petroleum), heavy clarified oil solvent, condensed-ring-arom.-contg. 

68783–00–6 ............. Extracts (petroleum), heavy naphthenic distillate solvent, arom. conc. 

68783–01–7 ............. Extracts (petroleum), heavy naphthenic distillate solvent, paraffinic conc. 

68783–02–8 ............. Extracts (petroleum), intermediate clarified oil solvent, condensed-ring-arom.-contg. 

68783–04–0 ............. Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent 

68783–05–1 ............. Gases (petroleum), ammonia-hydrogen sulfide, water-satd. 

68783–06–2 ............. Gases (petroleum), hydrocracking low-pressure separator 

68783–07–3 ............. Gases (petroleum), refinery blend 

68783–08–4 ............. Gas oils (petroleum), heavy atmospheric 

68783–09–5 ............. Naphtha (petroleum), catalytic cracked light distd. 

68783–12–0 ............. Naphtha (petroleum), unsweetened 

68783–13–1 ............. Residues (petroleum), coker scrubber, condensed-ring-arom.-contg. 

68783–15–3 ............. Alkenes, C6-7 .alpha.-

68783–61–9 ............. Fuel gases, refinery, sweetened 

68783–62–0 ............. Fuel gases, refinery, unsweetened 

68783–64–2 ............. Gases (petroleum), catalytic cracking 

68783–65–3 ............. Gases (petroleum), C2-4, sweetened 

68783–66–4 ............. Naphtha (petroleum), light, sweetened 

68814–47–1 ............. Waste gases, refinery vent 

68814–67–5 ............. Gases (petroleum), refinery 

68814–89–1 ............. Extracts (petroleum), heavy paraffinic distillates, solvent-deasphalted 

68814–87–9 ............. Distillates (petroleum), full-range straight-run middle 

68814–90–4 ............. Gases (petroleum), platformer products separator off 

68814–91–5 ............. Alkenes, C5-9 .alpha.-

68855–57–2 ............. Alkenes, C6-12 .alpha.-

68855–58–3 ............. Alkenes, C10-16 .alpha.-

68855–59–4 ............. Alkenes, C14-18 .alpha.-

68855–60–7 ............. Alkenes, C14-20 .alpha.-

68911–58–0 ............. Gases (petroleum), hydrotreated sour kerosine depentanizer stabilizer off 

68911–59–1 ............. Gases (petroleum), hydrotreated sour kerosine flash drum 

68915–96–8 ............. Distillates (petroleum), heavy straight-run 

68915–97–9 ............. Gas oils (petroleum), straight-run, high-boiling 

68918–69–4 ............. Petrolatum (petroleum), oxidized, zinc salt 

68918–73–0 ............. Residues (petroleum), clay-treating filter wash 

68918–93–4 ............. Paraffin waxes and Hydrocarbon waxes, oxidized, alkali metal salts 

68918–98–9 ............. Fuel gases, refinery, hydrogen sulfide-free 

68918–99–0 ............. Gases (petroleum), crude oil fractionation off 

68919–00–6 ............. Gases (petroleum), dehexanizer off 

68919–01–7 ............. Gases (petroleum), distillate unifiner desulfurization stripper off 

68919–02–8 ............. Gases (petroleum), fluidized catalytic cracker fractionation off 

68919–03–9 ............. Gases (petroleum), fluidized catalytic cracker scrubbing secondary absorber off 

68919–04–0 ............. Gases (petroleum), heavy distillate hydrotreater desulfurization stripper off 

68919–05–1 ............. Gases (petroleum), light straight run gasoline fractionation stabilizer off 

68919–06–2 ............. Gases (petroleum), naphtha unifiner desulfurization stripper off 

68919–07–3 ............. Gases (petroleum), platformer stabilizer off, light ends fractionation 

68919–08–4 ............. Gases (petroleum), preflash tower off, crude distn. 

68919–09–5 ............. Gases (petroleum), straight-run naphtha catalytic reforming off 

68919–10–8 ............. Gases (petroleum), straight-run stabilizer off 

68919–11–9 ............. Gases (petroleum), tar stripper off 

68919–12–0 ............. Gases (petroleum), unifiner stripper off 

68919–15–3 ............. Hydrocarbons, C6-12, benzene-recovery 

68919–17–5 ............. Hydrocarbons, C12-20, catalytic alkylation by-products 

68919–19–7 ............. Gases (petroleum), fluidized catalytic cracker splitter residues 

68919–20–0 ............. Gases (petroleum), fluidized catalytic cracker splitter overheads 

68919–37–9 ............. Naphtha (petroleum), full-range reformed 

68920–06–9 ............. Hydrocarbons, C7-9

68920–07–0 ............. Hydrocarbons, C<10-linear 

68920–64–9 ............. Disulfides, di-C1-2-alkyl 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 899

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED ‘‘PETROLEUM PROCESS STREAMS’’ FOR

PURPOSES OF INVENTORY UPDATE REPORTING—Continued

CAS No. Product 

68921–07–3 ............. Distillates (petroleum), hydrotreated light catalytic cracked 

68921–09–5 ............. Distillates (petroleum), naphtha unifiner stripper 

68921–08–4 ............. Distillates (petroleum), light straight-run gasoline fractionation stabilizer overheads 

68921–67–5 ............. Hydrocarbons, ethylene-manuf.-by-product distn. residues 

68952–76–1 ............. Gases (petroleum), catalytic cracked naphtha debutanizer 

68952–77–2 ............. Tail gas (petroleum), catalytic cracked distillate and naphtha stabilizer 

68952–78–3 ............. Tail gas (petroleum), catalytic hydrodesulfurized distillate fractionation stabilizer, hydrogen sulfide-free 

68952–79–4 ............. Tail gas (petroleum), catalytic hydrodesulfurized naphtha separator 

68952–80–7 ............. Tail gas (petroleum), straight-run naphtha hydrodesulfurizer 

68952–81–8 ............. Tail gas (petroleum), thermal-cracked distillate, gas oil and naphtha absorber 

68952–82–9 ............. Tail gas (petroleum), thermal cracked hydrocarbon fractionation stabilizer, petroleum coking 

68953–80–0 ............. Benzene, mixed with toluene, dealkylation product 

68955–27–1 ............. Distillates (petroleum), petroleum residues vacuum 

68955–28–2 ............. Gases (petroleum), light steam-cracked, butadiene conc. 

68955–31–7 ............. Gases (petroleum), butadiene process, inorg. 

68955–32–8 ............. Natural gas, substitute, steam-reformed desulfurized naphtha 

68955–33–9 ............. Gases (petroleum), sponge absorber off, fluidized catalytic cracker and gas oil desulfurizer overhead 

fractionation 

68955–34–0 ............. Gases (petroleum), straight-run naphtha catalytic reformer stabilizer overhead 

68955–35–1 ............. Naphtha (petroleum), catalytic reformed 

68955–36–2 ............. Residues (petroleum), steam-cracked, resinous 

68955–76–0 ............. Aromatic hydrocarbons, C9-16, biphenyl deriv.-rich 

68955–96–4 ............. Disulfides, dialkyl and di-Ph, naphtha sweetening 

68956–47–8 ............. Fuel oil, isoprene reject absorption 

68956–48–9 ............. Fuel oil, residual, wastewater skimmings 

68956–52–5 ............. Hydrocarbons, C4-8

68956–54–7 ............. Hydrocarbons, C4-unsatd. 

68956–55–8 ............. Hydrocarbons, C5-unsatd. 

68956–70–7 ............. Petroleum products, C5-12, reclaimed, wastewater treatment 

68988–79–4 ............. Benzene, C10-12-alkyl derivs., distn. residues 

68988–99–8 ............. Phenols, sodium salts, mixed with sulfur compounds, gasoline alk. scrubber residues 

68989–88–8 ............. Gases (petroleum), crude distn. and catalytic cracking 

68990–35–2 ............. Distillates (petroleum), arom., hydrotreated, dicyclopentadiene-rich 

68991–49–1 ............. Alkanes, C10-13, arom.-free desulfurized 

68991–50–4 ............. Alkanes, C14-17, arom.-free desulfurized 

68991–51–5 ............. Alkanes, C10-13, desulfurized 

68991–52–6 ............. Alkenes, C10-16

69013–21–4 ............. Fuel oil, pyrolysis 

69029–75–0 ............. Oils, reclaimed 

69430–33–7 ............. Hydrocarbons, C6-30

70024–88–3 ............. Ethene, thermal cracking products 

70528–71–1 ............. Distillates (petroleum), heavy distillate solvent ext. heart-cut 

70528–72–2 ............. Distillates (petroleum), heavy distillate solvent ext. vacuum overheads 

70528–73–3 ............. Residues (petroleum), heavy distillate solvent ext. vacuum 

70592–76–6 ............. Distillates (petroleum), intermediate vacuum 

70592–77–7 ............. Distillates (petroleum), light vacuum 

70592–78–8 ............. Distillates (petroleum), vacuum 

70592–79–9 ............. Residues (petroleum), atm. tower, light 

70693–00–4 ............. Hydrocarbon waxes (petroleum), oxidized, sodium salts 

70693–06–0 ............. Aromatic hydrocarbons, C9-11

70913–85–8 ............. Residues (petroleum), solvent-extd. vacuum distilled atm. residuum 

70913–86–9 ............. Alkanes, C18-70

70955–08–7 ............. Alkanes, C4-6

70955–09–8 ............. Alkenes, C13-14 .alpha.-

70955–10–1 ............. Alkenes, C15-18 .alpha.-

70955–17–8 ............. Aromatic hydrocarbons, C12-20

71243–66–8 ............. Hydrocarbon waxes (petroleum), clay-treated, microcryst., oxidized, potassium salts 

71302–82–4 ............. Hydrocarbons, C5-8, Houdry butadiene manuf. by-product 

71329–37–8 ............. Residues (petroleum), catalytic cracking depropanizer, C4-rich 

71808–30–5 ............. Tail gas (petroleum), thermal cracking absorber 

72230–71–8 ............. Distillates (petroleum), cracked steam-cracked, C5-17 fraction 

72623–83–7 ............. Lubricating oils (petroleum), C>25, hydrotreated bright stock-based 

72623–84–8 ............. Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based, contg. solvent deasphalted residual 

oil 

72623–85–9 ............. Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, high-viscosity 

72623–86–0 ............. Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based 

72623–87–1 ............. Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based 

93762–80–2 ............. Alkenes, C15-18

900 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

(2) Specific exempted chemical 

substances—(i) Exemption. EPA has 

determined that, at this time, the 

information in § 710.52(c)(4) associated 

with the chemicals listed in paragraph 

(b)(2)(iv) of this section is of low current 

interest. 

(ii) Considerations. In making its 

determination of whether this partial 

exemption should apply to a particular 

chemical substance, EPA will consider 

the totality of information available for 

the chemical substance in question, 

including but not limited to, one or 

more of the following considerations: 

(A) Whether the chemical qualifies or 

has qualified in past IUR collections for 

the reporting of the information 

described in § 710.52(c)(4) (i.e., at least 

one site manufactures 300,000 pounds 

or more of the chemical). 

(B) The chemical substance’s 

chemical and physical properties or 

potential for persistence, 

bioaccumulation, health effects, or 

environmental effects (considered 

independently or together). 

(C) The information needs of EPA, 

other federal agencies, tribes, states, and 

local governments, as well as members 

of the public. 

(D) The availability of other 

complementary risk screening 

information. 

(E) The availability of comparable 

processing and use information. 

(F) Whether the potential risks of the 

chemical substance are adequately 

managed by EPA or another agency or 

authority. 

(iii) Amendments. EPA may amend 

the chemical list in paragraph (b)(2)(iv) 

of this section on its own initiative or 

in response to a request from the public 

based on EPA’s determination of 

whether the information in 

§ 710.52(c)(4) is of low interest. 

(A) Any person may request that EPA 

amend the chemical list in paragraph 

(b)(2)(iv) of this section. Your request 

must be in writing and must be 

submitted to the address provided in 

§ 710.59(d). Requests must identify the 

chemical in question, as well as its CAS 

Number or other chemical identification 

number as identified in § 710.52(c)(3)(i). 

Your request should provide sufficient 

information for EPA to determine 

whether collection of the information in 

§ 710.52(c)(4) for the chemical in 

question is of low interest. In preparing 

your request, please refer to the 

considerations outlined in paragraph 

(b)(2)(ii) of this section. If a request 

related to a particular chemical is 

resubmitted, any subsequent request 

must clearly identify new information 

contained in the request. EPA may 

request other information that it 

believes necessary to evaluate the 

request. EPA will issue a written 

response to each request within 120 

days of receipt of the request, and will 

maintain copies of these responses in a 

public docket that will be established 

for each reporting cycle. 

(B) As needed, the Agency will 

initiate rulemaking to make revisions to 

the list in paragraph (b)(2)(iv) of this 

section. 

(C) To assist EPA in reaching a 

decision regarding a particular request 

prior to a given reporting year, requests 

must be submitted to EPA no later than 

12 months prior to the start of the 

reporting year, i.e., by January 1, 2004, 

or by each January 1 at 4–year intervals 

thereafter. 

(iv) List of chemical substances. EPA 

has designated the following chemical 

substances, listed by CAS Number, as 

partially exempt from reporting under 

the IUR.

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES UNDER § 710.46(B)(2) 

CAS No. Chemical 

50–70–4 ................... D-Glucitol 

50–81–7 ................... L-Ascorbic acid 

50–99–7 ................... D-Glucose 

56–87–1 ................... L-Lysine 

57–50–1 ................... .alpha.-D-Glucopyranoside, .beta.-D-fructofuranosyl 

58–95–7 ................... 2H-1-Benzopyran-6-ol, 3,4-dihydro-2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12- trimethyltridecyl]-, acetate, (2R)- 59–02–9 ................... 2H-1-Benzopyran-6-ol, 3,4-dihydro-2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12- trimethyltridecyl]-, (2R)-

59–51–8 ................... Methionine 

69–65–8 ................... D-Mannitol 

87–79–6 ................... L-Sorbose 

123–94–4 ................. Octadecanoic acid, 2,3-dihydroxypropyl ester 

124–38–9 ................. Carbon dioxide 

137–08–6 ................. .beta.-Alanine, N-[(2R)-2,4-dihydroxy-3,3-dimethyl-1-oxobutyl]-, calcium alt (2:1) 

142–47–2 ................. L-Glutamic acid, monosodium salt 

150–30–1 ................. Phenylalanine 

1317–65–3 ............... Limestone 

1333–74–0 ............... Hydrogen 

1592–23–0 ............... Octadecanoic acid, calcium salt 

7440–37–1 ............... Argon 

7440–44–0 ............... Carbon 

7727–37–9 ............... Nitrogen 

7782–42–5 ............... Graphite 

7782–44–7 ............... Oxygen 

8001–21–6 ............... Sunflower oil 

8001–22–7 ............... Soybean oil 

8001–23–8 ............... Safflower oil 

8001–26–1 ............... Linseed oil 

8001–29–4 ............... Cottonseed oil 

8001–30–7 ............... Corn oil 

8001–31–8 ............... Coconut oil 

8001–78–3 ............... Castor oil, hydrogenated 

8001–79–4 ............... Castor oil 

8002–03–7 ............... Peanut oil 

8002–13–9 ............... Rape oil 

8002–43–5 ............... Lecithins 

8002–75–3 ............... Palm oil 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 901

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES UNDER § 710.46(B)(2)—Continued

CAS No. Chemical 

8006–54–0 ............... Lanolin 

8016–28–2 ............... Lard, oil 

8016–70–4 ............... Soybean oil, hydrogenated 

8021–99–6 ............... Charcoal, bone 

8029–43–4 ............... Syrups, hydrolyzed starch 

9004–53–9 ............... Dextrin 

9005–25–8 ............... Starch 

9050–36–6 ............... Maltodextrin 

11103–57–4 ............. Vitamin A 

16291–96–6 ............. Charcoal 

26836–47–5 ............. D-Glucitol, monooctadecanoate 

61789–44–4 ............. Fatty acids, castor-oil 

61789–97–7 ............. Tallow 

61789–99–9 ............. Lard 

64147–40–6 ............. Castor oil, dehydrated 

64755–01–7 ............. Fatty acids, tallow, calcium salts 

65996–63–6 ............. Starch, acid-hydrolyzed 

65996–64–7 ............. Starch, enzyme-hydrolyzed 

67701–01–3 ............. Fatty acids, C12-18

68002–85–7 ............. Fatty acids, C14-22 and C16-22-unsatd. 

68131–37–3 ............. Syrups, hydrolyzed starch, dehydrated 

68188–81–8 ............. Grease, poultry 

68308–54–3 ............. Glycerides, tallow mono-, di- and tri-, hydrogenated 

68334–00–9 ............. Cottonseed oil, hydrogenated 

68334–28–1 ............. Fats and glyceridic oils, vegetable, hydrogenated 

68409–76–7 ............. Bone meal, steamed 

68424–45–3 ............. Fatty acids, linseed-oil 

68424–61–3 ............. Glycerides, C16-18 and C18-unsatd. mono- and di68425–17–2 ............. Syrups, hydrolyzed starch, hydrogenated 

68439–86–1 ............. Bone, ash 

68442–69–3 ............. Benzene, mono-C10-14-alkyl derivs. 

68476–78–8 ............. Molasses 

68514–27–2 ............. Grease, catch basin 

68514–74–9 ............. Palm oil, hydrogenated 

68525–87–1 ............. Corn oil, hydrogenated 

68648–86–2 ............. Benzene, C14-16-alkyl derivs. 

68648–87–3 ............. Benzene, C10-16-alkyl derivs. 

68918–42–3 ............. Soaps, stocks, soya 

68952–94–3 ............. Soaps, stocks, vegetable-oil 

68989–98–0 ............. Fats and glyceridic oils, vegetable, residues 

73138–67–7 ............. Lard, hydrogenated 

129813–58–7 ........... Benzene, mono-C10-13-alkyl derivs. 

129813–59–8 ........... Benzene, mono-C12-14-alkyl derivs. 

129813–60–1 ........... Benzene, mono-C14-16-alkyl derivs. 

(3) Inorganic chemical substances. 

For purposes of this subpart, an 

inorganic chemical substance is any 

chemical substance which does not 

contain carbon or contains carbon only 

in the form of carbonato [=CO3], cyano 

[--CN], cyanato [--OCN], isocyano [--NC], 

or isocyanato [--NCO] groups or the 

chalcogen analogues of such groups. 

During the 2006 submission period, 

manufacturers are excluded only from 

the reporting requirements under 

§ 710.52(c)(4) for inorganic chemical 

substances. During the 2006 submission 

period, manufacturers of inorganic 

chemical substances are not excluded 

from the other reporting requirements 

under this part. During submission 

periods following the 2006 submission 

period, manufacturers of inorganic 

chemical substances are subject to all of 

the reporting requirements in this 

subpart.

§ 710.48 Persons who must report. 

Except as provided in § § 710.49 and 

710.50, the following persons are 

subject to the requirements of this 

subpart. Persons must determine 

whether they must report under this 

section for each chemical substance that 

they manufacture (including import) at 

an individual site. 

(a) Persons subject to recurring 

reporting. Any person who 

manufactured (including imported) for 

commercial purposes 25,000 lbs. 

(11,340 kg) or more of a chemical 

substance described in § 710.45 at any 

single site owned or controlled by that 

person at any time during calendar year 

2005 or during the calendar year at 4–

year intervals thereafter is subject to 

reporting. 

(b) Special provisions for importers. 

For purposes of this section, the site for 

a person who imports a chemical 

substance described in § 710.45 is the 

site of the operating unit within the 

person’s organization which is directly 

responsible for importing the substance 

and which controls the import 

transaction. The import site may in 

some cases be the organization’s 

headquarters in the United States (see 

also § 710.55(b)).

§ 710.49 Persons not subject to this 

subpart. 

A person described in § 710.48 is not 

subject to the requirements of this 

subpart if that person qualifies as a 

small manufacturer as that term is 

defined in § 704.3 of this chapter. 

Notwithstanding this exclusion, a 

902 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

person who qualifies as a small 

manufacturer is subject to this subpart 

with respect to any chemical substance 

that is the subject of a rule proposed or 

promulgated under section 4, 5(b)(4), or 

6 of the Act, or is the subject of an order 

in effect under section 5(e) of the Act, 

or is the subject of relief that has been 

granted under a civil action under 

section 5 or 7 of the Act.

§ 710.50 Activities for which reporting is 

not required. 

A person described in § 710.48 is not 

subject to the requirements of this 

subpart with respect to any chemical 

substance described in § 710.45 that the 

person solely manufactured or imported 

under the following circumstances: 

(a) The person manufactured or 

imported the chemical substance 

described in § 710.45 solely in small 

quantities for research and 

development. 

(b) The person imported the chemical 

substance described in § 710.45 as part 

of an article. 

(c) The person manufactured the 

chemical substance described in 

§ 710.45 in a manner described in 

§ 720.30(g) or (h) of this chapter.

§ 710.52 Reporting information to EPA. 

Any person who must report under 

this subpart, as described in § 710.48, 

must submit the information described 

in this section for each chemical 

substance described in § 710.45 that the 

person manufactured (including 

imported) for commercial purposes in 

an amount of 25,000 lbs. (11,340 kg) or 

more at any one site during calendar 

year 2005 or during the calendar year at 

4–year intervals thereafter. (See 

§ 710.48(b) for the ‘‘site’’ for importers). 

A separate form must be submitted for 

each chemical substance at each site for 

which the submitter is required to 

report. A submitter of information under 

this subpart must report information as 

described in paragraphs (c)(1), (c)(2), 

and (c)(3) of this section to the extent 

that such information is known to or 

reasonably ascertainable by that person 

whereas a submitter must report 

information as described in paragraph 

(c)(4) of this section only to the extent 

that such information is readily 

obtainable by that person. A submitter 

under this subpart must report 

information that applies to the calendar 

year for which the person is required to 

report (i.e., calendar year 2005 and the 

calendar year at 4–year intervals 

thereafter). 

(a) Reporting in writing. Any person 

who chooses to report information to 

EPA in writing must do so by 

completing the reporting form available 

from EPA at the address set forth in 

§ 710.59. The form must include all 

information described in paragraph (c) 

of this section. Persons reporting in 

writing must submit a separate form for 

each site for which the person is 

required to report. 

(b) Reporting by magnetic media. Any 

person who chooses to report 

information to EPA by means of 

magnetic media must submit the 

information described in paragraph (c) 

of this section. Magnetic media 

submitted in response to this subpart 

must meet EPA specifications, as 

described in the instruction booklet 

available from EPA at the address set 

forth in § 710.59. 

(c) Information to be reported. 

Manufacturers (including importers) of 

a reportable chemical substance in an 

amount of 25,000 lbs. (11,340 kg) or 

more at a site during a reporting year 

must report the information described 

in paragraphs (c)(1), (c)(2), and (c)(3) of 

this section. Manufacturers (including 

importers) of a reportable chemical 

substance in an amount of 300,000 lbs. 

(136,077 kg) or more at a site during a 

reporting year must report the 

information described in paragraph 

(c)(4) of this section in addition to the 

information described in paragraphs 

(c)(1), (c)(2), and (c)(3) of this section. 

As described in § 710.46(b)(3), 

manufacturers of certain inorganic 

chemical substances are not required to 

report the information described in 

paragraph (c)(4) of this section during 

the 2006 submission period, but are 

required to report this information 

during subsequent submission periods. 

As described in § 710.46(b)(1) and (b)(2), 

manufacturers of certain chemicals are 

not required to report the information 

described in paragraph (c)(4) of this 

section. 

(1) A certification statement signed 

and dated by an authorized official of 

the submitter company. Persons 

reporting by means of magnetic media 

must submit this information on the 

reporting form available as described in 

§ 710.59. 

(2) Company and plant site 

information. The following company 

and plant site information must be 

reported for each site at which at least 

25,000 lbs. (11,340 kg) of a reportable 

chemical substance is manufactured 

(including imported) during calendar 

year 2005 or during the calendar year at 

4–year intervals thereafter (see 

§ 710.48(b) for the ‘‘site’’ for importers): 

(i) The name of a person who will 

serve as technical contact for the 

submitter company, and who will be 

able to answer questions about the 

information submitted by the company 

to EPA, the parent company name and 

Dun and Bradstreet Number, the contact 

person’s full mailing address, the 

contact person’s telephone number and 

the contact person’s e-mail address. 

(ii) The name and full street address 

of each site. A submitter under this 

subpart must include the appropriate 

Dun and Bradstreet Number for each 

plant site reported, and the county or 

parish (or other jurisdictional indicator) 

in which the plant site is located. 

(3) Specific information for chemicals 

manufactured in amounts of 25,000 lbs. 

or more. The following chemicalspecific information must be reported 

for each reportable chemical substance 

manufactured at (including imported 

into) each site in amounts of 25,000 lbs. 

(11,340 kg) or more during calendar year 

2005 or during the calendar year at 4–

year intervals thereafter: 

(i) The specific chemical name and 

CAS Number of each reportable 

chemical substance at each site. A 

submitter under this subpart may use an 

EPA-designated Accession Number for 

confidential substances, or a 

premanufacture notice (PMN) case 

number (see § 720.65 of this chapter) in 

lieu of a CAS Number when a CAS 

Number is not known to or reasonably 

ascertainable by the submitter. In 

addition to reporting the number itself, 

submitters must specify the type of 

number they are reporting by selecting 

from among the following codes:

CODES TO SPECIFY TYPE OF

CHEMICAL IDENTIFYING NUMBER

Codes Number Type 

A ................. Accession Number 

C ................. CAS Registry Number 

P ................. PMN Number 

(ii) A statement indicating, for each 

reportable chemical substance at each 

site, whether the substance is 

manufactured in the United States, 

imported into the United States, or both 

manufactured in the United States and 

imported into the United States. 

(iii) A designation indicating, for each 

reportable chemical substance at each 

site, whether the substance is sitelimited. 

(iv) The total volume (in pounds) of 

each reportable chemical substance 

manufactured (including imported) at 

each site. This amount must be reported 

to two significant figures of accuracy 

provided that the reported figures are 

within plus or minus 10% of the actual 

volume. 

(v) Any person claiming that the 

volume reported under paragraph 

(c)(3)(iv) of this section is confidential 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 903

business information under § 710.58 

must indicate, for each reportable 

chemical substance at each site, whether 

the total volume range (in pounds) 

which corresponds with the specific 

volume figure reported in response to 

paragraph (c)(3)(iv) of this section is 

also confidential. Volume ranges are 

listed in the following table:

VOLUME RANGES

From To 

25,000 lbs. ................ 300,000 lbs. 

300,000 lbs. .............. 1,000,000 lbs. 

1,000,000 lbs. ........... 10,000,000 lbs. 

10,000,000 lbs. ......... 50,000,000 lbs. 

50,000,000 lbs. ......... 100,000,000 lbs. 

100,000,000 lbs. ....... 500,000,000 lbs. 

500,000,000 lbs. ....... 1,000,000,000 lbs. 

Greater than 

1,000,000,000 lbs..

(vi) The total number of workers 

reasonably likely to be exposed to each 

reportable chemical substance at each 

site. For each reportable substance at 

each site, the submitter must select from 

among the ranges of workers listed in 

the following table and report the 

corresponding code (i.e., W1 through 

W8):

CODES FOR REPORTING NUMBER OF

WORKERS REASONABLY LIKELY TO

BE EXPOSED

Codes Range 

W1 .............. Less than 10 workers 

W2 .............. At least 10 but less than 25 

workers 

W3 .............. At least 25 but less than 50 

workers 

W4 .............. At least 50 but less than 100 

workers 

W5 .............. At least 100 but less than 500 

workers 

W6 .............. At least 500 but less than 

1,000 workers 

W7 .............. At least 1,000 but less than 

10,000 workers 

W8 .............. At least 10,000 workers 

(vii) The maximum concentration, 

measured by percentage of weight, of 

each reportable chemical substance at 

the time it is sent off-site from each site. 

If the chemical is site-limited, you must 

report the maximum concentration, 

measured by percentage of weight, of 

the reportable chemical substance at the 

time it is reacted on-site to produce a 

different chemical substance. This 

information must be reported regardless 

of the physical form(s) in which the 

substance is sent off-site/reacted on-site. 

For each substance at each site, select 

the maximum concentration of the 

substance from among the ranges listed 

in the following table and report the 

corresponding code (i.e., M1 through 

M5):

CODES FOR REPORTING MAXIMUM

CONCENTRATION OF CHEMICAL SUBSTANCE

Codes Concentration Range (% 

weight) 

M1 .............. Less than 1% by weight 

M2 .............. From 1 to 30% by weight 

M3 .............. From 31 to 60% by weight 

M4 .............. From 61 to 90% by weight 

M5 .............. Greater than 90% by weight 

(viii) The physical form(s) of the 

reportable chemical substance as it is 

sent off-site from each site. If the 

chemical is site-limited, you must report 

the physical form(s) of the reportable 

chemical substance at the time it is 

reacted on-site to produce a different 

chemical substance. For each substance 

at each site, the submitter must report 

as many physical forms as apply from 

among the physical forms listed below: 

(A) Dry powder. 

(B) Pellets or large crystals. 

(C) Water- or solvent-wet solid. 

(D) Other solid. 

(E) Gas or vapor. 

(F) Liquid. 

(ix) Submitters must report the 

percentage, rounded off to the closest 

10%, of total production volume of the 

reportable chemical substance, reported 

in response to paragraph (c)(3)(iv) of 

this section, that is associated with each 

physical form reported under paragraph 

(c)(3)(viii) of this section. The sum of 

the percentages reported must not add 

up to more than 100%. 

(4) Specific information for chemical 

substances manufactured in amounts of 

300,000 lbs. or more. In addition to the 

information required under paragraphs 

(c)(1), (c)(2), and (c)(3) of this section, 

the following information must be 

reported for each reportable chemical 

substance manufactured (including 

imported) in an amount of 300,000 lbs. 

(136,077 kg) or more at any one site 

during calendar year 2005 or during the 

calendar year at 4–year intervals 

thereafter. Persons subject to paragraph 

(c)(4) of this section must report the 

information described in paragraphs 

(c)(4)(i) and (c)(4)(ii) of this section for 

each reportable chemical substance at 

sites under their control and at sites that 

receive a reportable chemical substance 

from the submitter directly or indirectly 

(including through a broker/distributor, 

from a customer of the submitter, etc.). 

Information reported in response to this 

paragraph must be reported only to the 

extent that it is readily obtainable by the 

submitter. If information responsive to a 

given data requirement under this 

paragraph, including information in the 

form of an estimate, is not readily 

obtainable, the submitter is not required 

to respond to the requirement. 

(i) Industrial processing and use 

information. 

(A) A designation indicating the type 

of industrial processing or use 

operation(s) at each site that receives a 

reportable substance from the submitter 

site directly or indirectly (whether the 

recipient site(s) are controlled by the 

submitter site or not). For each chemical 

substance, report the letters which 

correspond to the appropriate 

processing or use operation(s). A 

particular designation may need to be 

reported more than once, to the extent 

that a submitter reports more than one 

NAICS code (under paragraph 

(c)(4)(i)(B) of this section) that applies to 

a given designation under this 

paragraph.

Designation Operation 

PC ............ Processing as a reactant 

PF ............. Processing - incorporation into 

formulation, mixture or reaction product 

PA ............ Processing - incorporation into 

article 

PK ............ Processing - repackaging 

U ............... Use - non-incorporative activities 

(B) The five-digit North American 

Industrial Classification System 

(NAICS) codes which best describe the 

industrial activities associated with 

each industrial processing or use 

operation reported under paragraph 

(c)(4)(i)(A) of this section. Information 

about how to find these codes is 

provided in the instruction booklet 

available from EPA at the address set 

forth in § 710.59. A particular NAICS 

code may need to be reported more than 

once, to the extent that a submitter 

reports more than one industrial 

function code (under paragraph 

(c)(4)(i)(C) of this section) that applies to 

a given NAICS code under this 

paragraph. 

(C) For each NAICS code reported 

under paragraph (c)(4)(i)(B) of this 

section, code(s) from the following list 

must be selected to designate the 

industrial function category(ies) that 

best represents the specific manner in 

which the chemical substance is used. 

A particular industrial function category 

may need to be reported more than 

once, to the extent that a submitter 

reports more than one industrial 

processing or use operation/NAICS code 

904 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

combination (under paragraphs 

(c)(4)(i)(A) and (c)(4)(i)(B) of this 

section) that applies to a given 

industrial function category under this 

paragraph. If more than 10 unique 

combinations of industrial processing or 

use operations/NAICS codes/industrial 

function categories apply to a chemical 

substance, submitters need only report 

the 10 unique combinations for the 

chemical substance that cumulatively 

represent the largest percentage of the 

submitter’s production volume for that 

chemical, measured by weight.

CODES FOR REPORTING INDUSTRIAL

FUNCTION CATEGORIES

Codes Category 

U01 ............. Adsorbents and absorbents 

U02 ............. Adhesives and binding agents 

U03 ............. Aerosol propellants 

U04 ............. Agricultural chemicals (nonpesticidal) 

U05 ............. Anti-adhesive agents 

U06 ............. Bleaching agents 

U07 ............. Coloring agents, dyes 

U08 ............. Coloring agents, pigments 

U09 ............. Corrosion inhibitors and antiscaling agents 

U10 ............. Fillers 

U11 ............. Fixing agents 

U12 ............. Flame retardants 

U13 ............. Flotation agents 

U14 ............. Fuels 

U15 ............. Functional fluids 

U16 ............. Intermediates 

U17 ............. Lubricants 

U18 ............. Odor agents 

U19 ............. Oxidizing agents 

U20 ............. pH-regulating agents 

U21 ............. Photosensitive chemicals 

U22 ............. Plating agents and metal surface treating agents 

U23 ............. Processing aid, not otherwise 

listed 

U24 ............. Process regulators, used in 

vulcanization or polymerization processes 

U25 ............. Process regulators, other than 

polymerization or vulcanization processes 

U26 ............. Reducing agents 

U27 ............. Solvents (for cleaning or 

degreasing) 

U28 ............. Solvents (which become part 

of product formulation or 

mixture) 

U29 ............. Solvents (for chemical manufacture and processing and 

are not part of product at 

greater than one percent by 

weight) 

U30 ............. Stabilizers 

U31 ............. Surface active agents 

U32 ............. Viscosity adjustors 

U33 ............. Other 

(D) The estimated percentage, 

rounded off to the closest 10%, of total 

production volume of the reportable 

chemical substance associated with 

each combination of industrial 

processing or use operation, NAICS 

code and industrial function category. 

Where a particular combination of 

industrial processing or use operation, 

NAICS code and industrial function 

category accounts for 5% or less of the 

submitter’s site’s total production 

volume of a reportable chemical 

substance, the percentage must not be 

rounded off to zero % if the production 

volume attributable to that industrial 

processing or use operation, NAICS 

code and industrial function category 

combination is 300,000 lbs. (136,077 kg) 

or more during the reporting year. 

Instead, in such a case, submitters must 

report the percentage, rounded off to the 

closest 1%, of the submitter’s site’s total 

production volume of the reportable 

chemical substance associated with the 

particular combination of industrial 

processing or use operation, NAICS 

code and industrial function category. 

(E) For each combination of industrial 

processing or use operation, NAICS 

code and industrial function category, 

the submitter must estimate the number 

of sites at which each reportable 

chemical substance is processed or 

used. For each combination associated 

with each substance, the submitter must 

select from among the ranges of sites 

listed in the following table and report 

the corresponding code (i.e., S1 through 

S7):

CODES FOR REPORTING NUMBERS OF

SITES

Codes Range 

S1 ............... Less than 10 sites 

S2 ............... From 10 to 25 sites 

S3 ............... From 25 to 100 sites 

S4 ............... From 100 to 250 sites 

S5 ............... From 250 to 1,000 sites 

S6 ............... From 1,000 to 10,000 sites 

S7 ............... More than 10,000 sites 

(F) For each combination of industrial 

processing or use operation, NAICS 

code and industrial function category, 

the submitter must estimate the number 

of workers reasonably likely to be 

exposed to each reportable chemical 

substance. For each combination 

associated with each substance, the 

submitter must select from among the 

worker ranges listed in paragraph 

(c)(3)(vi) of this section and report the 

corresponding code (i.e., W1 though 

W8). 

(ii) Commercial and consumer use 

information. 

(A) Using the codes listed in this 

paragraph, submitters must designate 

the commercial and consumer product 

category or categories that best describe 

the commercial and consumer products 

in which each reportable chemical 

substance is used (whether the recipient 

site(s) are controlled by the submitter 

site or not). If more than 10 codes apply 

to a chemical substance, submitters 

need only report the 10 codes for the 

chemical substance that cumulatively 

represent the largest percentage of the 

submitter’s production volume for that 

chemical, measured by weight:

CODES FOR REPORTING COMMERCIAL

AND CONSUMER PRODUCT CATEGORIES

Codes Category 

C01 ............. Artists’ supplies 

C02 ............. Adhesives and sealants 

C03 ............. Automotive care products 

C04 ............. Electrical and electronic products 

C05 ............. Glass and ceramic products 

C06 ............. Fabrics, textiles and apparel 

C07 ............. Lawn and garden products 

(non-pesticidal) 

C08 ............. Leather products 

C09 ............. Lubricants, greases and fuel 

additives 

C10 ............. Metal products 

C11 ............. Paper products 

C12 ............. Paints and coatings 

C13 ............. Photographic chemicals 

C14 ............. Polishes and sanitation goods 

C15 ............. Rubber and plastic products 

C16 ............. Soaps and detergents 

C17 ............. Transportation products 

C18 ............. Wood and wood furniture 

C19 ............. Other 

(B) Submitters must determine, 

within each commercial and consumer 

product category reported under 

paragraph (c)(4)(ii)(A) of this section, 

whether any amount of each reportable 

chemical substance manufactured 

(including imported) by the submitter is 

present in (for example, a plasticizer 

chemical used to make pacifiers) or on 

(for example, as a component in the 

paint on a toy) any consumer products 

intended for use by children up to the 

age of 14, regardless of the 

concentration of the substance 

remaining in or on the product. 

Submitters must select from the 

following options: the chemical 

substance is used in or on any consumer 

products intended for use by children, 

the chemical substance is not used in or 

on any consumer products intended for 

use by children, or information as to 

whether the chemical substance is used 

in or on any consumer products 

intended for use by children is not 

readily obtainable. 

(C) The estimated percentage, 

rounded off to the closest 10%, of the 

submitter’s site’s total production 

volume of the reportable chemical 

substance associated with each 

commercial and consumer product 

Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 905

category. Where a particular commercial 

and consumer product category 

accounts for 5% or less of the total 

production volume of a reportable 

chemical substance, the percentage 

must not be rounded off to zero % if the 

production volume attributable to that 

commercial and consumer product 

category is 300,000 lbs. (136,077 kg) or 

more during the reporting year. Instead, 

in such a case, submitters must report 

the percentage, rounded off to the 

closest 1%, of the submitter’s site’s total 

production volume of the reportable 

chemical substance associated with the 

particular commercial and consumer 

product category. 

(D) Where the reportable chemical 

substance is used in commercial or 

consumer products, the estimated 

typical maximum concentration, 

measured by weight, of the chemical 

substance in each commercial and 

consumer product category reported 

under paragraph (c)(4)(ii)(A) of this 

section. For each substance in each 

commercial and consumer product 

category reported under paragraph 

(c)(4)(ii)(A) of this section, submitters 

must select from among the ranges of 

concentrations listed in the table in 

paragraph (c)(3)(vii) of this section and 

report the corresponding code (i.e., M1 

through M5).

§ 710.53 When to report. 

All information reported to EPA in 

response to the requirements of this 

subpart must be submitted during an 

applicable submission period. The first 

submission period is from August 25, 

2006, to December 23, 2006. Subsequent 

recurring submission periods are from 

August 25 to December 23 at 4–year 

intervals after the first submission 

period. Any person described in 

§ 710.48(a) must report during each 

submission period for each chemical 

substance described in § 710.45 that the 

person manufactured (including 

imported) during the preceding calendar 

year (i.e., the ‘‘reporting year’’).

§ 710.55 Duplicative reporting. 

(a) With regard to section 8(a) rules. 

Any person subject to the requirements 

of this part who previously has 

complied with reporting requirements 

of a rule under section 8(a) of the Act 

by submitting the information described 

in § 710.52 for a chemical substance 

described in § 710.45 to EPA, and has 

done so within 1 year of the start of a 

submission period described in 

§ 710.53, is not required to report again 

on the manufacture of that substance at 

that site during that submission period. 

(b) With regard to importers. This part 

requires that only one report be 

submitted on each import transaction 

involving a chemical substance 

described in § 710.45. When two or 

more persons are involved in a 

particular import transaction and each 

person meets the Agency’s definition of 

‘‘importer’’ as set forth in § § 710.3 and 

704.3 of this chapter, they may 

determine among themselves who 

should submit the required report; if no 

report is submitted as required under 

this part, EPA will hold each such 

person liable for failure to report.

§ 710.57 Recordkeeping requirements. 

Each person who is subject to the 

reporting requirements of this subpart 

must maintain records that document 

any information reported to EPA. 

Records relevant to reporting during a 

submission period must be retained for 

a period of 5 years beginning with the 

effective date of that submission period.

§ 710.58 Confidentiality. 

(a) Any person submitting 

information under this subpart may 

assert a business confidentiality claim 

for the information at the time it is 

submitted. These claims will apply only 

to the information submitted with the 

claim. New confidentiality claims, if 

necessary, must be asserted with regard 

to information submitted during the 

next submission period. Guidance for 

asserting confidentiality claims is 

provided in the instruction booklet 

identified in § 710.59. Information 

claimed as confidential in accordance 

with this section will be treated and 

disclosed in accordance with the 

procedures in part 2 of this chapter. 

(b) Chemical identity. A person may 

assert a claim of confidentiality for the 

chemical identity of a specific chemical 

substance only if the identity of that 

substance is treated as confidential in 

the Master Inventory File as of the time 

the report is submitted for that 

substance under this subpart. The 

following steps must be taken to assert 

a claim of confidentiality for the 

identity of a reportable chemical 

substance: 

(1) The submitter must submit with 

the report detailed written answers to 

the following questions signed and 

dated by an authorized official. 

(i) What harmful effects to your 

competitive position, if any, do you 

think would result from the identity of 

the chemical substance being disclosed 

in connection with reporting under this 

subpart? How could a competitor use 

such information? Would the effects of 

disclosure be substantial? What is the 

causal relationship between the 

disclosure and the harmful effects? 

(ii) How long should confidential 

treatment be given? Until a specific 

date, the occurrence of a specific event, 

or permanently? Why? 

(iii) Has the chemical substance been 

patented? If so, have you granted 

licenses to others with respect to the 

patent as it applies to the chemical 

substance? If the chemical substance has 

been patented and therefore disclosed 

through the patent, why should it be 

treated as confidential? 

(iv) Has the identity of the chemical 

substance been kept confidential to the 

extent that your competitors do not 

know it is being manufactured or 

imported for a commercial purpose by 

anyone? 

(v) Is the fact that the chemical 

substance is being manufactured 

(including imported) for a commercial 

purpose available to the public, for 

example in technical journals, libraries, 

or State, local, or Federal agency public 

files? 

(vi) What measures have been taken to 

prevent undesired disclosure of the fact 

that the chemical substance is being 

manufactured (including imported) for a 

commercial purpose? 

(vii) To what extent has the fact that 

this chemical substance is manufactured 

(including imported) for commercial 

purposes been revealed to others? What 

precautions have been taken regarding 

these disclosures? Have there been 

public disclosures or disclosures to 

competitors? 

(viii) Does this particular chemical 

substance leave the site of manufacture 

(including import) in any form, e.g., as 

product, effluent, emission? If so, what 

measures have been taken to guard 

against the discovery of its identity? 

(ix) If the chemical substance leaves 

the site in a product that is available to 

the public or your competitors, can the 

substance be identified by analysis of 

the product? 

(x) For what purpose do you 

manufacture (including import) the 

substance? 

(xi) Has EPA, another Federal agency, 

or any Federal court made any pertinent 

confidentiality determinations regarding 

this chemical substance? If so, please 

attach copies of such determinations. 

(2) If any of the information contained 

in the answers to the questions listed in 

paragraph (b)(1) of this section is 

asserted to contain confidential business 

information, the submitter must clearly 

identify the information that is claimed 

confidential by marking the specific 

information on each page with a label 

such as ‘‘confidential business 

information,’’ ‘‘proprietary,’’ or ‘‘trade 

secret.’’

906 Federal Register / Vol. 68, No. 4 / Tuesday, January 7, 2003 / Rules and Regulations 

(c) Site identity. A submitter may 

assert a claim of confidentiality for a site 

only if the linkage of the site with a 

reportable chemical is confidential and 

not publicly available. The following 

steps must be taken to assert a claim of 

confidentiality for a site identity: 

(1) The submitter must submit with 

the report detailed written answers to 

the following questions signed and 

dated by an authorized official: 

(i) Has site information been linked 

with a chemical identity in any other 

Federal, state or local reporting scheme? 

For example, is the chemical identity 

linked to a facility in a filing under the 

Emergency Planning and Community 

Right-to-Know Act (EPCRA) section 311, 

namely through a Material Safety Data 

Sheet (MSDS)? If so, identify all such 

schemes. Was the linkage claimed as 

confidential in any of these instances? 

(ii) What harmful effect, if any, to 

your competitive position do you think 

would result from the identity of the site 

and the chemical substance being 

disclosed in connection with reporting 

under this subpart? How could a 

competitor use such information? 

Would the effects of disclosure be 

substantial? What is the causal 

relationship between the disclosure and 

the harmful effects? 

(2) If any of the information contained 

in the answers to the questions listed in 

paragraph (c)(1) of this section is 

asserted to contain confidential business 

information, the submitter must clearly 

identify the information that is claimed 

confidential by marking the specific 

information on each page with a label 

such as ‘‘confidential business 

information,’’ ‘‘proprietary,’’ or ‘‘trade 

secret.’’

(d) If no claim of confidentiality is 

indicated on the reporting form 

submitted to EPA under this subpart, or 

if confidentiality claim substantiation 

required under paragraphs (c) and (d) of 

this section is not submitted with the 

reporting form, EPA may make the 

information available to the public 

without further notice to the submitter.

§ 710.59 Availability of reporting form and 

instructions. 

(a) Use the proper EPA form. You 

must use the EPA form identified as 

‘‘Form U’’ to submit written information 

in response to the requirements of this 

subpart. Copies of Form U are available 

from EPA at the address set forth in 

paragraph (c) of this section and from 

the EPA Internet Home Page at http://

www.epa.gov/oppt/iur. 

(b) Follow the reporting instructions. 

Guidance for completing the reporting 

form and preparing an electronic 

(magnetic media) report will be made 

available prior to each submission 

period. 

(c) Obtain the reporting package and 

copies of the form. EPA will send a 

reporting package (consisting of a copy 

of Form U and a copy of the reporting 

instructions) to those submitters that 

reported in the IUR submission period 

that occurred immediately prior to the 

current submission period. Failure to 

receive a reporting package does not 

obviate or otherwise affect the 

requirement to submit a timely report. If 

you did not receive a reporting package, 

but are required to report, you may 

obtain a copy of the reporting package 

from EPA by submitting a request for 

this information as follows: 

(1) By telephone. Call the EPA TSCA 

Hotline at 202–554–1404. 

(2) By e-mail. Send an e-mail request 

for this information to the EPA TSCA 

Hotline at TSCA-Hotline@epa.gov. 

(3) By mail. Send a written request for 

this information to the following 

address: TSCA Hotline, Mailcode 

7408M, ATTN: Inventory Update Rule, 

Office of Pollution Prevention and 

Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460. 

(4) By Internet. To download a copy 

of the form and/or instructions go to: 

http://www.epa.gov/oppt/iur. 

(d) Submit the completed reports. You 

must submit your completed reporting 

form(s) and/or magnetic media to EPA 

at the following address: OPPT 

Document Control Officer (DCO), 

Mailcode 7407M, ATTN: Inventory 

Update Rule, Office of Pollution 

Prevention and Toxics, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460. 

3. Part 723 is amended as follows:

PART 723—[AMENDED] 

a. The authority citation for part 723 

continues to read as follows:

Authority: 15 U.S.C. 2604.

b. In § 723.175, revise paragraph (b)(3) 

to read as follows:

§ 723.175 Premanufacture Notification 

Exemptions

* * * * *

(b) Definitions.***

(3) The terms byproduct, EPA, 

impurities, person, and site have the 

same meanings as in § 710.3 of this 

chapter.

* * * * *

[FR Doc. 02–32909 Filed 12–31–02; 9:56 am] 

BILLING CODE 6560–50–S